HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS
FDA 510(k) clearance K081506 · decided 2008-07-25
Clearance details
- K-number
- K081506
- Device name
- HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS
- Applicant
- Hyperbaric America, LLC
- Decision
- Substantially Equivalent
- Date received
- 2008-05-29
- Decision date
- 2008-07-25
- Days to decision
- 57 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
+ Add to Predicate Builder ◉ Watch Hyperbaric America
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.