Device Classification Name |
Imager, Ultrasonic Obstetric-Gynecologic
|
510(k) Number |
K880900 |
Device Name |
SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER |
Applicant |
COROMETRICS MEDICAL SYSTEMS, INC. |
61 BARNES PARK RD. NORTH |
P.O. BOX 333 |
WALLINGFORD,
CT
06492
|
|
Applicant Contact |
JOSEPH P LENZEN |
Correspondent |
COROMETRICS MEDICAL SYSTEMS, INC. |
61 BARNES PARK RD. NORTH |
P.O. BOX 333 |
WALLINGFORD,
CT
06492
|
|
Correspondent Contact |
JOSEPH P LENZEN |
Regulation Number | 884.2225
|
Classification Product Code |
|
Date Received | 03/02/1988 |
Decision Date | 06/01/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|