OxyHeal 4000 Multiplace Hyperbaric Chamber Family
FDA 510(k) clearance K163109 · decided 2017-03-22
Clearance details
- K-number
- K163109
- Device name
- OxyHeal 4000 Multiplace Hyperbaric Chamber Family
- Applicant
- Oxyheal Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-11-07
- Decision date
- 2017-03-22
- Days to decision
- 135 days
- Clearance type
- Special
- Product code
- CBF
- Device class
- 2
- Regulation number
- 868.5470
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- National City, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.