510(k) DEN170056
- Device
- Parathyroid Detection (Model PTeye) System
- Applicant
- Aibiomed, Corp.
- 510(k) number
- DEN170056
- Product code
- QDF
- Decision
- Unknown (DENG)
- Decision date
- 2018-11-02
- Date received
- 2017-09-25
- Regulation
- 878.4550
- Classification name
- Parathyroid Autofluorescence Detection Device
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Al Memmolo
- Address
- 107 W. Gutierrez Sreet Santa Barbara CA US 93101 93101
FDA Registration Numbers#
- 1045254
- 1625507
- 3018094310
Source Documents#
510(k) summary PDF not indicated by FDA