Device Classification Name |
Computer, Diagnostic, Programmable
|
510(k) Number |
K152160 |
Device Name |
Navik 3D |
Applicant |
APN Health, LLC |
4900 Hopyard Road, Suite 100 |
Pleasanton,
CA
94588
|
|
Applicant Contact |
David Geddam |
Correspondent |
Decus Biomedical Inc |
2342 Shattuck Ave, #333 |
Berkeley,
CA
94704
|
|
Correspondent Contact |
Grace Bartoo |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 08/03/2015 |
Decision Date | 02/23/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|