510(k) K151357

MIRI TL by At Medical Uab — Product Code MQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2016
Date Received
May 20, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6120
Review Panel
OB
Submission Type