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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Processor, Radiographic-Film, Automatic
510(k) Number K992818
Device Name OPTIMAX/ COMPACT 2
Applicant
Protec GmbH & Co. KG
Lichtenberger St. 35
Oberstenfeld,  DE 71720
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607
Correspondent Contact CAROLE STAMP
Regulation Number892.1900
Classification Product Code
IXW  
Date Received08/20/1999
Decision Date 09/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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