Device Classification Name |
system, imaging, pulsed echo, ultrasonic
|
510(k) Number |
K170133 |
Device Name |
FFR V2.5 |
Applicant |
Philips Volcano |
3721 Valley Ctr. Dr. |
San Diego,
CA
92130
|
|
Applicant Contact |
Elaine Alan |
Correspondent |
Philips Volcano |
3721 Valley Ctr. Dr. |
San Diego,
CA
92130
|
|
Correspondent Contact |
Elaine Alan |
Regulation Number | 892.1560
|
Classification Product Code |
|
Date Received | 01/17/2017 |
Decision Date | 05/26/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|