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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K837142
Device Name TRANSDUCERS MODELS 421, 419 AND 420 FOR IREX SYSTEM
Applicant
Hoffrel Instruments, Inc.
345 Wilson Ave.
P.O. Box 5825
South Norwalk,  CT  06854
Correspondent
Hoffrel Instruments, Inc.
345 Wilson Ave.
P.O. Box 5825
South Norwalk,  CT  06854
Date Received01/03/1983
Decision Date 03/23/1983
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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