DEPARTMENT OF HEALTH &HUMAN SERVICES Public Hecalth Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MID 20993-0002
Mr. Joseph E.Olsavsky 

## NOV -4 

## 2011 Sr. Manager, Regulatory Affairs Respironics Incorporated 1740 Golden Mile Highway Monroeville, Pennsylvania 15146
Re: Kll11885 Trade/Device Name: Respironics SimplyGo Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: 11 Product Code: CAW Dated: October 6,2011 Received: October 7,2011
Dear Mr. Olsavsky: We have reviewed your Section 510(k) premarket notification ofintent to market the device referenced above and have determined the device issubstantially equivalent (for the in~dic-i3iidiiforu~FstatcciA n£he enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May28, 1976, the enactment date ofthe Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval ofa prernarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions ofthe Act. The general controls provisions ofthe Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties: We remind you, however, that device labeling must be truthful and not misleading. Ifyour device isclassified (see above) into either class 11 (Special Controls) or class III (PMA), itmay be subject to additional controls. Existing major regulations affecting your device can be found in the Code ofFederal Regulations, Title 21,Parts 800 to 898. In addition, FDA may publish further announcements concerning your device inthe Federal Register.Page 2
- Mr. Olsavsky
Please be advised that FDA's issuance ofa substantial equivalence determination does not mean that FDA has made a determination thatyour device complies with other requirements ofthe Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CER Part 807); labeling (21 CFR Part 801); medical device reporting (reporting ofmedical device-related adverse events) (21 CFll 803); good manufacturing practice requirements as set forth in the quality systems (QS)regulation (21 CFR Part 820); and ifapplicable, the electronic product radiation control provisions (Sections 53 1-542 of the Act); 21 CFR 1000-1050. Ifyou desire specific advice foryour device on our labeling regulation (21 CFR Part 801), please go to htp/wwfapvAotD/etr~fcsCR/DIIfie /ucmlI 1 5809.htm forthe Center forDevices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reportirig of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda gov/Medica1Devices/Safety/ReportaProblem/default htm for the CDRH' s Office ofSurveillance and Biometrics/Division ofPostmarket Surveillance. You may obtain other general information on yourresponsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.I'da.gov/MedicalDevices/ResourcesforYou/1ndustry/default~htm. Sincerely yours,

Anthony D.Watson, B.S., M.S., M.B.A. Director Division ofAnesthesiology, General Hospital, Infection Control and Dental Devices Office ofDevice Evaluation Center for Devices and

Radiological Health

EnclosureRespironics SimplyGo Oxygen Concentrator Premarket Notification

- Special 510(k)

Section 6.0 Indications for Use

Indications for Use 

### 51 0(k) Number (ifknown): 

# iA'i 5B5 Device Name: Respironics SimplyGo Oxygen Concentrator
The Respironics SimnplyGo Portable Oxygen Concentrator isfor prescription use by patients requiring high concentrations ofoxygen on asupplemental basis. Itissmall, portable and iscapable ofcontinuous use in the home, institutional, and travel /mobile environments.

Prescription Use ___X AN/R Over-The-Counter Use

____ (Part 21 CFR 801 Subpart D) AN/R(21 CER 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence ofCDRH, Office ofDevice Evaluation (ODE) 

### (DivisionSign-Off) DivisionofAnesthesiology, General Hospital InfectionControl, Dental Devices 

## 510(k) Number: 

## /- 1, '?/ 

## I

- a aeIo 00019