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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, mobile
510(k) Number K012379
Device Name PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM
Applicant
TREX ENTERPRISES CORP.
10455 PACIFIC CENTER CT.
SAN DIEGO,  CA  92121 -4339
Applicant Contact PETER J MARTIN
Correspondent
TREX ENTERPRISES CORP.
10455 PACIFIC CENTER CT.
SAN DIEGO,  CA  92121 -4339
Correspondent Contact PETER J MARTIN
Regulation Number892.1720
Classification Product Code
IZL  
Date Received07/26/2001
Decision Date 08/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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