HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS— 510(k) K081506
Substantially EquivalentHyperbaric America, LLC
FDA 510(k) clearance K081506 for HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS, Substantially Equivalent on 2008-07-25. Applicant: Hyperbaric America, LLC.
Clearance details
- Applicant
- Hyperbaric America, LLC
- Product code
- Code CBF
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- San Antonio, TX, US
Adverse events under product code CBF
product code CBF- Death
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.