TANSCU O2
FDA 510(k) clearance K090681 · decided 2009-08-12
Clearance details
- K-number
- K090681
- Device name
- TANSCU O2
- Applicant
- Electrochemical Oxygen Concepts, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-03-16
- Decision date
- 2009-08-12
- Days to decision
- 149 days
- Clearance type
- Abbreviated
- Product code
- KPJ
- Device class
- 2
- Regulation number
- 878.5650
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Lake Bluff, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.