Device Classification Name |
Cystometer, Electrical Recording
|
510(k) Number |
K920574 |
Device Name |
CAMSYS 6300 |
Applicant |
F.M. WIEST USA, INC. |
690 KINDERKAMACK RD., 1ST FL. |
P.O. BOX 637 |
ORADELL,
NJ
07649
|
|
Applicant Contact |
GEORGE BATCHELOR |
Correspondent |
F.M. WIEST USA, INC. |
690 KINDERKAMACK RD., 1ST FL. |
P.O. BOX 637 |
ORADELL,
NJ
07649
|
|
Correspondent Contact |
GEORGE BATCHELOR |
Regulation Number | 876.1620
|
Classification Product Code |
|
Date Received | 02/07/1992 |
Decision Date | 02/17/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|