Device Classification Name |
cystometric gas (carbon-dioxide) on hydraulic device
|
510(k) Number |
K842124 |
Device Name |
EMG MODULE, EMG1, W/OPTIONAL SPEAKER |
Applicant |
ENDOTEK CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
ENDOTEK CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 876.1620
|
Classification Product Code |
|
Date Received | 05/29/1984 |
Decision Date | 08/08/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|