Device Classification Name |
accessory, assisted reproduction
|
510(k) Number |
K111715 |
Device Name |
EMBRYOSCOPE |
Applicant |
UNISENSE FERTILITECH A/S |
TUEAGER 1 |
ARRHUS N,
DK
DK-8200
|
|
Applicant Contact |
METTE MUNCH |
Correspondent |
UNISENSE FERTILITECH A/S |
TUEAGER 1 |
ARRHUS N,
DK
DK-8200
|
|
Correspondent Contact |
METTE MUNCH |
Regulation Number | 884.6120
|
Classification Product Code |
|
Date Received | 06/20/2011 |
Decision Date | 08/11/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01138631
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|