Device Classification Name |
lithotriptor, ultrasonic
|
510(k) Number |
K171024 |
Device Name |
ShockPulse-SE Lithotripsy System |
Applicant |
Cybersonics, Inc. |
Knowledge Park, 5340 Fryling Road, Suite 101 |
Erie,
PA
16510
|
|
Applicant Contact |
Samradni Patil |
Correspondent |
Cybersonics, Inc. |
Knowledge Park, 5340 Fryling Road, Suite 101 |
Erie,
PA
16510
|
|
Correspondent Contact |
Samradni Patil |
Regulation Number | 876.4480
|
Classification Product Code |
|
Date Received | 04/05/2017 |
Decision Date | 08/21/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|