Cylinder, Compressed Gas, And Valve

Device Code: 123

Product Code(s): ECX

Device Classification Information

• Device Type ID: 123
• Device Name: Cylinder, Compressed Gas, And Valve
• Regulation Description: Pressure Regulator.
• 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) Exempt
• CFR Regulation Number: 868.2700 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: ECX
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 123
• Device: Cylinder, Compressed Gas, And Valve
• Product Code: ECX
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Pressure Regulator.
• CFR Regulation Number: 868.2700 [🔎]

Premarket Reviews
Manufacturer	Decision
AIR LIQUIDE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	1
AIR LIQUIDE HEALTHCARE AMERICA
	SUBSTANTIALLY EQUIVALENT	1
AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ESSEX INDUSTRIES, INC
	SUBSTANTIALLY EQUIVALENT	1
PRAXAIR, INC.
	SUBSTANTIALLY EQUIVALENT	1
THE SCOTT FETZER CO.
	SUBSTANTIALLY EQUIVALENT	1
Western - A Scott Fetzer Company
	SUBSTANTIALLY EQUIVALENT	1

TPLC Last Update: 2019-04-02 19:29:22