Parathyroid Detection (Model PTeye) System
FDA 510(k) clearance DEN170056 · decided 2018-11-02
Clearance details
- K-number
- DEN170056
- Device name
- Parathyroid Detection (Model PTeye) System
- Applicant
- Aibiomed, Corp.
- Decision
- Unknown
- Date received
- 2017-09-25
- Decision date
- 2018-11-02
- Days to decision
- 403 days
- Clearance type
- Direct
- Product code
- QDF
- Device class
- 2
- Regulation number
- 878.4550
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Santa Barbara, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.