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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K042698
Device Name UNFORS PATIENT SKIN DOSIMETER (PSD)
Applicant
Unfors, Inc.
123 Litchfield Rd.
New Milford,  CT  06776
Applicant Contact PATRICK R PYERS
Correspondent
Unfors, Inc.
123 Litchfield Rd.
New Milford,  CT  06776
Correspondent Contact PATRICK R PYERS
Regulation Number892.1650
Classification Product Code
JAA  
Date Received09/30/2004
Decision Date 10/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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