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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 K852194
Device Name MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET
Applicant
Sharp Electronics Corp.
10 Sharp Plz.
P.O. Box 588
Paramus,  NJ  07652
Applicant Contact GLEN L WEINBERG
Correspondent
Sharp Electronics Corp.
10 Sharp Plz.
P.O. Box 588
Paramus,  NJ  07652
Correspondent Contact GLEN L WEINBERG
Classification Product Code
LHD  
Date Received05/20/1985
Decision Date 09/27/1985
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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