SIGMA SERIES HYPERBARIC CHAMBER
FDA 510(k) clearance K072427 · decided 2008-06-11
Clearance details
- K-number
- K072427
- Device name
- SIGMA SERIES HYPERBARIC CHAMBER
- Applicant
- Perry Baromedical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2007-08-29
- Decision date
- 2008-06-11
- Days to decision
- 287 days
- Clearance type
- Abbreviated
- Product code
- CBF
- Device class
- 2
- Regulation number
- 868.5470
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Rivera Beach, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.