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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K844404
Device Name IREX PS, PORTABLE SCANNER AND 118
Applicant
Irex Corp.
69 Spring St.
Ramsey,  NJ  07446
Applicant Contact RAYMOND F CHASE
Correspondent
Irex Corp.
69 Spring St.
Ramsey,  NJ  07446
Correspondent Contact RAYMOND F CHASE
Regulation Number892.1560
Classification Product Code
IYO  
Date Received11/13/1984
Decision Date 02/04/1985
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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