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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Fertility Diagnostic, Proceptive
510(k) Number K845009
Device Name RABBIT-PERSONAL COMPUTER FOR WOMEN
Applicant
Sanimor, Inc.
144 S. Beverly Dr.
Suite 501
Beverly Hills,  CA  90212
Applicant Contact GERALD R NEWMAN
Correspondent
Sanimor, Inc.
144 S. Beverly Dr.
Suite 501
Beverly Hills,  CA  90212
Correspondent Contact GERALD R NEWMAN
Classification Product Code
LHD  
Date Received12/26/1984
Decision Date 04/10/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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