510(k) K160504

RI Witness Embryology Heated Plate by Research Instruments Limited — Product Code MQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2016
Date Received
February 24, 2016
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