Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.)

Device Code: 106

Product Code(s): CBR

Device Classification Information

• Device Type ID: 106
• Device Name: Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.)
• Regulation Description: Nitrous Oxide Gas Analyzer.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); Anesthesiology Devices Branch (ANDB)
• Submission Type: 510(k)
• CFR Regulation Number: 868.1700 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: CBR
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 1-96 ISO 80601-2-55 First Edition 2011-12-15
  Medical Electrical Equipment - Part 2-55: Particular Requirements For The Basic Safety And Essential Performance Of Respiratory Gas Monitors
• 1-140 ISO 80601-2-55 Second Edition 2018-02
  Medical Electrical Equipment - Part 2-55: Particular Requirements For The Basic Safety And Essential Performance Of Respiratory Gas Monitors

Total Product Life Cycle

• Device Type ID: 106
• Device: Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.)
• Product Code: CBR
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Nitrous Oxide Gas Analyzer.
• CFR Regulation Number: 868.1700 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	Spacelabs Healthcare Inc	II	Jul-17-2014

TPLC Last Update: 2019-04-02 19:29:09