Device Classification Name |
Imager, Ultrasonic Obstetric-Gynecologic
|
510(k) Number |
K905000 |
Device Name |
ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER |
Applicant |
COROMETRICS MEDICAL SYSTEMS, INC. |
61 BARNES PARK RD. NORTH |
P.O. BOX 333 |
WALLINGFORD,
CT
06492
|
|
Applicant Contact |
BRIAN R BARRY |
Correspondent |
COROMETRICS MEDICAL SYSTEMS, INC. |
61 BARNES PARK RD. NORTH |
P.O. BOX 333 |
WALLINGFORD,
CT
06492
|
|
Correspondent Contact |
BRIAN R BARRY |
Regulation Number | 884.2225
|
Classification Product Code |
|
Date Received | 11/07/1990 |
Decision Date | 01/31/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|