BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER
FDA 510(k) clearance K020974 · decided 2002-06-26
Clearance details
- K-number
- K020974
- Device name
- BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER
- Applicant
- Environmental Tectonics Corp.
- Decision
- Unknown
- Date received
- 2002-03-26
- Decision date
- 2002-06-26
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- CBF
- Device class
- 2
- Regulation number
- 868.5470
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Southampton, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.