510(k) K845009

RABBIT-PERSONAL COMPUTER FOR WOMEN by Sanimor, Inc. — Product Code LHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1985
Date Received
December 26, 1984
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