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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name image-intensified fluoroscopic x-ray system, mobile
510(k) Number K900194
Device Name MTHF-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT
Applicant
IMT AMERICA, INC.
120 EAST BALTIMORE ST.
BALTIMORE,  MD  21202
Applicant Contact PEGGY CHAPLIN
Correspondent
IMT AMERICA, INC.
120 EAST BALTIMORE ST.
BALTIMORE,  MD  21202
Correspondent Contact PEGGY CHAPLIN
Regulation Number892.1650
Classification Product Code
OXO  
Date Received01/16/1990
Decision Date 05/07/1990
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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