510(k) DEN170056
DEN170056 is an FDA 510(k) premarket notification submitted by Aibiomed, Corp. for the device "Parathyroid Detection (Model PTeye) System". The FDA issued a decision of De Novo granted on Nov 2, 2018. The device falls under product code QDF (Parathyroid Autofluorescence Detection Device), a Class II device regulated under 21 CFR 878.4550.
Clearance Details
- Decision
- DENG (De Novo granted)
- Decision Date
- Nov 2, 2018
- Date Received
- Sep 25, 2017
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Parathyroid Autofluorescence Detection Device
- Device Class
- Class II
- Regulation Number
- 878.4550
- Review Panel
- SU
- Submission Type
- 510(k)
An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.