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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 K810832
Device Name FORECASTER
Applicant
Forecaster Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Forecaster Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Classification Product Code
LHD  
Date Received03/25/1981
Decision Date 06/24/1981
Decision Substantially Equivalent (SESE)
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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