EMBRYOSCOPE


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

Correspodent Contact mette munch
Regulation Number 884.6120
Classification Product Code
MQG  
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