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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K950288
Device Name AUTOLASER MULTI FORMAT CAMERA
Applicant
AFP IMAGING CORP.
250 CLEARBROOK RD.
ELMSFORD,  NY  10523
Applicant Contact DAVID VOZICK
Correspondent
AFP IMAGING CORP.
250 CLEARBROOK RD.
ELMSFORD,  NY  10523
Correspondent Contact DAVID VOZICK
Regulation Number892.2040
Classification Product Code
LMC  
Date Received01/25/1995
Decision Date 04/04/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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