Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=37509
Timestamp: 2019-09-17 02:25:17
Document Index: 152778074

Matched Legal Cases: ['§868', '§868', '§868', '§868', '§868', '§868', '§868']

FR Recognition Number 1-140
ISO 80601-2-55 Second edition 2018-02
FDA recognition of ISO 80601-2-55 First edition 2011-12-15 [Rec# 1-96] will be superseded by recognition of ISO 80601-2-55 Second edition 2018-02 [Rec# 1-140]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-96] until September 28, 2019. After this transition period, declarations of conformity to [Rec# 1-96] will not be accepted.
§868.1720 Analyzer, Gas, Oxygen, Gaseous-Phase Class 2 CCL
§868.1700 Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Class 2 CBR
§868.1620 Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Class 2 CBS
§868.1500 Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Class 2 NHO
§868.1500 Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Class 2 CBQ
§868.1500 Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Class 2 NHQ
§868.1500 Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Class 2 NHP