01 / 04 / 08 FR I 17:5 2 FAX C D

RH FDA ODE

**~00 1**  DEPARTMENT OF IIBALTH & HUMAN S ERVICES Publ l c H telth Service 

### J AN - 3 

## !108 Food and Drug Adm iniatratlon 9200 CorpOf'ete Boulevard Rockville M O 2:0850
D

elphi Medical Systems C

/ 0 Mr. Je ff D . Ron gero Senior Pr ojec t Engineer Underwr it

ers Laboratories, In corporated 12 Labor atory Drive Researc h T riang le , North Carolina 

### 27709 Re : K07324 2 Tra deJDevice Name: Portable Oxygen Concentrator Regulation Number : 868.5440 R

egu lation Name: Portable Oxygen Genera to r Regula tory C l ass: II Produ ct Code: · CAW Da t ed: D ecemb er 17 ,2007 Received : D ecember 

### 19 , 2007 Dear 

### Mr. Rongero: We have revi ew ed your Section S l O (k) premarket notifi cati on of int en t to market the devi ce referenced abov e and hav e determined the device is substantial ly equivalent (for the indicatio ns for use stated in t he e nclo sure) to legally marketed predicate devi ce s mark eted in in t

ersta te commerce prior to Ma y 28, 19 76 , the enactment date of the Medical Device . A

mendments, or to devices th at 

### have been reclassified in accor dance with the pr ovisi o ns of the Fede ral Fo od, Drug , and Cos metic Act (Act) that do not r equire approval of a preJTUll'ket approva l application ( PMA) . Y ou may, therefore, mark et the device, sub ject to the general contro l s 

### provision s of the 

### A ct. The gen eral 

### controls pr ov i sions of the 

### Ac l include re q uir ements for annu al registration, list ing of devices, go od manuf acturi n g practice, labeling, and prohibiti ons aga inst misbranding and adulteration. If your de vice is c l assi fied (see above) int o eith e r clas s II (Spec ial Controls) or class 

### ill (P MA), it may be subject to such additi onal controls. Existing maj or re gul ation s affec ti ng your device can be found in th e Code of Federal Reguletions, Title 21, Parts 800 t o 898 . In

**~tuu on,**  FDA m ay pu blish further announc ements concerning ynur de vice in t h

e

**~eral**

**~·**



### 0 1/04/2008 4:52PM01 / 04 / 08 FRI 1 7 :53 FAX CDRH FDA ODE

. Page 2 - Mr. Rongero Please be a dvised that FDA ':s is:suuuce of a
**~ubstantial** equ ivale n ce determina ti on d oes n ot mean t hat FDA has made a d eter mination that you r device complie s with other requi rements of the Act or any Federal statute s and regulations administered by oth e r Federa l agencies. You mu s t com ply with all the Act 's requireme n ts, including, but not limited to : reg i stration and li stin g (21 CFR P art 807); l abeling (2 1 CFR Part 801); good manuf acturing practice requirem en ts as set f orth in the quality systems (QS) regulation ( 21 CFR Part 8 20) ; and if applicable, the electr onic product mdiati on control provisions (Sectio ns 531 - 54 2 of the Act); 2 1 CFR 1000 -105 0. This letter will allow you to begi n marketing yo ur dev ice as des c r ibed in your Section 5 1 O(k ) premarl<: et notification . The FDA finding of substantial equivalence of your device t o a le gally mar k

eted predica t e dev i ce res u lts in a classification for your device and thus, permits yo u r d.evice to p roceed to the market. If you desire specific advice fot your device on our labeling regulation (21 CFR Part 80 I), please contact the Office of Compliance at ( 240 ) 276 - 0 12 0. Also, please note the regulation entitl ed, "Mi sbrand ing by reference to premarket noti ficatio n " (2 1 C FR Part 807 . 97). You may obtain ot her general information on yo ur responsibilities under the Ac t from the Division of S mal l Manufactur ers, Intemat io 1!3.l and Consumer Ass istance at its toll - fTee number (800) 6 38 -204 1 or (301) 443 - 6597 or a t i

ts Internet add r ess

**tt!?: //**  **www.fda gov**  **/c drh/industry**  **supoortlindex htrnl**  **.**

Enclos ure 

# g, ce I yo ur s, 

# fl ·
**..12a.t~ -u**  **~Q** C . in, 

### Ph.D . . . D irec tor D ivision of Anesthesiology, General Hospital,

Infectio n CQntro l and Dental Devices Office of Device E valuation Center for Devices and

Radiological Health



### 0 1/ 04/2008 4:52PM **~0 2** 01 / 04 / 0 8 FR I 1 7 : 5 3 F AX C D

RB FD A OD E 

# DE:LPHI Medical Syst ems 5725 D e l p

hi Drive Troy , Ml 4 8098 ·2 81 5 USA

·sect i on IV : Ind ications for Use Statement Applicant: De lphi Med i cal System s 510(k ) N umbe r : D evi ce Name: P o rt able Oxygen Concentrator Indication s for Use: The Portab le Oxyg en Concentrato r i s Intended to pr ovi de s upp l emental oxyge n in a home , Insti tutiona l, or travel env iro n ment.

**Pr scrlption**  Use Only : _X_ Over-t he-Co unter Use : ( P L EASE DO NOT WRITE BELOW T HI S LINE - CONT INUE ON ANOTHER PAGE IF N E EDED ) .

P ortab l e Oxygen Concen trator · 0 1/ 0 4/2 0 08 4: 5 2PM **003**