PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2— 510(k) K021689
Substantially EquivalentPan-America Hyperbarics, Inc.
FDA 510(k) clearance K021689 for PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2, Substantially Equivalent on 2002-10-24. Applicant: Pan-America Hyperbarics, Inc..
Clearance details
- Applicant
- Pan-America Hyperbarics, Inc.
- 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.