Device Classification Name |
Uroflowmeter
|
510(k) Number |
K894968 |
Device Name |
ULTRACOMPACT |
Applicant |
EUTECTIC ELECTRONICS, INC. |
8608 JERSEY COURT |
RALEIGH,
NC
27612
|
|
Applicant Contact |
LARRY DANIEL |
Correspondent |
EUTECTIC ELECTRONICS, INC. |
8608 JERSEY COURT |
RALEIGH,
NC
27612
|
|
Correspondent Contact |
LARRY DANIEL |
Regulation Number | 876.1800
|
Classification Product Code |
|
Date Received | 08/07/1989 |
Decision Date | 11/08/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|