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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 K821507
Device Name SYMPTOTHERM 8 FERTILITY INDICATOR
Applicant
OVIX CORP., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
OVIX CORP., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Classification Product Code
LHD  
Date Received05/20/1982
Decision Date 10/14/1982
Decision Substantially Equivalent (SESE)
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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