Device Classification Name |
Media, Coupling, Ultrasound
|
510(k) Number |
K163026 |
Device Name |
Ultra/Phonic Scanning Gel |
Applicant |
Pharmaceutical Innovations Inc. |
897 Frelinghuysen Ave. |
Newark,
NJ
07114
|
|
Applicant Contact |
Shirley J. Bergman |
Correspondent |
Pharmaceutical Innovations Inc. |
897 Frelinghuysen Ave. |
Newark,
NJ
07114
|
|
Correspondent Contact |
Shirley J. Bergman |
Regulation Number | 892.1570
|
Classification Product Code |
|
Date Received | 10/31/2016 |
Decision Date | 01/09/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|