GAMOW HYPERBARIC BAG
FDA 510(k) clearance K874752 · decided 1988-02-02
Clearance details
- K-number
- K874752
- Device name
- GAMOW HYPERBARIC BAG
- Applicant
- Hyperbaric Aerobics, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1987-11-18
- Decision date
- 1988-02-02
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- CBF
- Device class
- 2
- Regulation number
- 868.5470
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Boulder, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.