Device Classification Name |
Cystometer, Electrical Recording
|
510(k) Number |
K931574 |
Device Name |
ADVANCE MODEL UDS-ADV |
Applicant |
LABORIE MEDICAL TECHNOLOGIES, LTD. |
6415 NORTHWEST DR. |
UNIT #11 |
MISSISSAUGA, ONTARIO,
CA
L4V 1X1
|
|
Applicant Contact |
FRED BUFFA |
Correspondent |
LABORIE MEDICAL TECHNOLOGIES, LTD. |
6415 NORTHWEST DR. |
UNIT #11 |
MISSISSAUGA, ONTARIO,
CA
L4V 1X1
|
|
Correspondent Contact |
FRED BUFFA |
Regulation Number | 876.1620
|
Classification Product Code |
|
Date Received | 03/30/1993 |
Decision Date | 08/05/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|