PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1
FDA 510(k) clearance K021690 · decided 2002-10-24
Clearance details
- K-number
- K021690
- Device name
- PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1
- Applicant
- Pan-America Hyperbarics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-05-22
- Decision date
- 2002-10-24
- Days to decision
- 155 days
- Clearance type
- Abbreviated
- Product code
- CBF
- Device class
- 2
- Regulation number
- 868.5470
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.