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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, ultrasonic, fetal
510(k) Number K852655
Device Name COMBISCOPE
Applicant
INSTRUMENT TECHNOLOGY, INC.
1961 OLD MIDDLEFIELD WAY
MOUNTAIN VIEW,  CA  94043
Applicant Contact ROBERT TETRAULT
Correspondent
INSTRUMENT TECHNOLOGY, INC.
1961 OLD MIDDLEFIELD WAY
MOUNTAIN VIEW,  CA  94043
Correspondent Contact ROBERT TETRAULT
Regulation Number884.2660
Classification Product Code
KNG  
Date Received06/24/1985
Decision Date 02/21/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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