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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K860235
Device Name MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCER
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 Number892.1570
Classification Product Code
ITX  
Date Received01/22/1986
Decision Date 05/15/1986
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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