Navik 3D
Computer, Diagnostic, Programmable
APN Health, LLC
The following data is part of a premarket notification filed by Apn Health, Llc with the FDA for Navik 3d.
Pre-market Notification Details
| Device ID | K152160 |
| 510k Number | K152160 |
| Device Name: | Navik 3D |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | APN Health, LLC 4900 Hopyard Road, Suite 100 Pleasanton, CA 94588 |
| Contact | David Geddam |
| Correspondent | Grace Bartoo Decus Biomedical Inc 2342 Shattuck Ave, #333 Berkeley, CA 94704 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-03 |
| Decision Date | 2016-02-23 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869781000308 | K152160 | 000 |
Trademark Results [Navik 3D]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NAVIK 3D 86047191 5041473 Live/Registered |
APN Health, LLC 2013-08-24 |
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