OxyHeal 4000 Multiplace Hyperbaric Chamber Family— 510(k) K163109
Substantially EquivalentOxyheal Medical Systems, Inc.
FDA 510(k) clearance K163109 for OxyHeal 4000 Multiplace Hyperbaric Chamber Family, Substantially Equivalent on 2017-03-22. Applicant: Oxyheal Medical Systems, Inc..
Clearance details
- Applicant
- Oxyheal Medical Systems, Inc.
- Product code
- Code CBF
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- National City, CA, 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.