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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 K915405
Device Name P1310 AUTOMATIC BRIGHTNESS STABILIZER (ABS)
Applicant
Precise Optics Photo Medic Equipment, Inc.
239 S. Fehr Way
Bay Shore,  NY  11706
Applicant Contact RON HANNINGTON
Correspondent
Precise Optics Photo Medic Equipment, Inc.
239 S. Fehr Way
Bay Shore,  NY  11706
Correspondent Contact RON HANNINGTON
Regulation Number892.1650
Classification Product Code
JAA  
Date Received12/02/1991
Decision Date 02/04/1992
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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