Chamber, Hyperbaric

Device Code: 96

Product Code(s): CBF

Device Classification Information

• Device Type ID: 96
• Device Name: Chamber, Hyperbaric
• Regulation Description: Hyperbaric Chamber.
• 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: 868.5470 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: CBF
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: Yes
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 1-67 NFPA 99:2005
  Standard For Health Care Facilities Chapter 20 - Hyperbaric Facilities
• 1-78 ASME PVHO-1-2007
  Safety Standard For Pressure Vessels For Human Occupancy

Total Product Life Cycle

• Device Type ID: 96
• Device: Chamber, Hyperbaric
• Product Code: CBF
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Hyperbaric Chamber.
• CFR Regulation Number: 868.5470 [🔎]

Premarket Reviews
Manufacturer	Decision
OXYHEAL MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
SECHRIST INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Device Operates Differently Than Expected	3
Device Dislodged Or Dislocated	2
Disconnection	2
No Apparent Adverse Event	1
Device Displays Incorrect Message	1
Adverse Event Without Identified Device Or Use Problem	1
Improper Device Output	1
Total Device Problems	11

Recalls
Manufacturer		Recall Class	Date Posted
1	Baro-Therapies, Inc	II	Sep-30-2014

TPLC Last Update: 2019-04-02 19:28:54