Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System— 510(k) K152223
Substantially EquivalentOxyheal Medical Systems, Inc.
FDA 510(k) clearance K152223 for Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System, Substantially Equivalent on 2016-04-29. 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
- Traditional
- 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.