510(k) K152160
K152160 is an FDA 510(k) premarket notification submitted by Apn Health, LLC for the device "Navik 3D". The FDA issued a decision of Substantially Equivalent on Feb 23, 2016. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 23, 2016
- Date Received
- Aug 3, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type
- 510(k)