Analyzer, Gas, Oxygen, Gaseous-phase

Device Code: 115

Product Code(s): CCL

Device Classification Information

• Device Type ID: 115
• Device Name: Analyzer, Gas, Oxygen, Gaseous-phase
• Regulation Description: Oxygen 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: 868.1720 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: CCL
• 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: 115
• Device: Analyzer, Gas, Oxygen, Gaseous-phase
• Product Code: CCL
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Oxygen Gas Analyzer.
• CFR Regulation Number: 868.1720 [🔎]

Premarket Reviews
Manufacturer	Decision
MAXTEC, LLC
	SUBSTANTIALLY EQUIVALENT	1
PRECISION MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
PRECISION MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Device Inoperable	2
Device Displays Incorrect Message	2
Calibration Problem	1
Total Device Problems	5

Recalls
Manufacturer		Recall Class	Date Posted
1	GE Healthcare	II	May-28-2015
2	GE Healthcare, LLC	II	Sep-09-2014
3	GE Healthcare, LLC	II	Jun-17-2014

TPLC Last Update: 2019-04-02 19:29:15