Device Classification Name |
Monitor, Heart Sound, Fetal, Ultrasonic
|
510(k) Number |
K060410 |
Device Name |
ECHOHEART TRANSVAGINAL DOPPLER PROBE |
Applicant |
SUMMIT DOPPLER SYSTEMS, INC. |
4620 TECHNOLOGY DR. UNIT 100 |
GOLDEN,
CO
80403
|
|
Applicant Contact |
KEN JARRELL |
Correspondent |
SUMMIT DOPPLER SYSTEMS, INC. |
4620 TECHNOLOGY DR. UNIT 100 |
GOLDEN,
CO
80403
|
|
Correspondent Contact |
KEN JARRELL |
Regulation Number | 884.2660
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/16/2006 |
Decision Date | 04/10/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|