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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 K925220
Device Name PMI100 VIDEO IMAGER
Applicant
Heraeus Kulzer, Inc.
1 Ramland Rd.
Orangeburg,  NY  10962
Applicant Contact MARK G KALAFUT
Correspondent
Heraeus Kulzer, Inc.
1 Ramland Rd.
Orangeburg,  NY  10962
Correspondent Contact MARK G KALAFUT
Regulation Number892.2040
Classification Product Code
LMC  
Date Received10/16/1992
Decision Date 05/20/1993
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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