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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K844916
Device Name MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER
Applicant
Hoffrel Instruments, Inc.
345 Wilson Ave.
P.O. Box 5825
South Norwalk,  CT  06854
Applicant Contact RUSSEL L UPHOFF
Correspondent
Hoffrel Instruments, Inc.
345 Wilson Ave.
P.O. Box 5825
South Norwalk,  CT  06854
Correspondent Contact RUSSEL L UPHOFF
Regulation Number892.1560
Classification Product Code
IYO  
Date Received12/18/1984
Decision Date 04/22/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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