Device Classification Name |
transducer, ultrasonic, obstetric
|
510(k) Number |
K860621 |
Device Name |
1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507 |
Applicant |
IMPEX MEDICAL SYSTEMS, INC. |
6355 JOYCE DR. |
GOLDEN,
CO
80403
|
|
Applicant Contact |
KIRK OLSEN |
Correspondent |
IMPEX MEDICAL SYSTEMS, INC. |
6355 JOYCE DR. |
GOLDEN,
CO
80403
|
|
Correspondent Contact |
KIRK OLSEN |
Regulation Number | 884.2960
|
Classification Product Code |
|
Date Received | 02/19/1986 |
Decision Date | 05/20/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|