510(k) K102499

DUOFERTILITY by Cambridge Temperature Concepts , Ltd. — Product Code LHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2011
Date Received
August 31, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Fertility Diagnostic, Proceptive
Device Class
Class U
Regulation Number
Review Panel
OB
Submission Type