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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 Doppler, Ultrasonic
510(k) Number K844293
Device Name AUTO DII MULTI FREQUENCY
Applicant
Technicare Corp.
90 Inverness Cir. E.
Englewood,  CO  80112
Applicant Contact DAVID A ENSOR
Correspondent
Technicare Corp.
90 Inverness Cir. E.
Englewood,  CO  80112
Correspondent Contact DAVID A ENSOR
Regulation Number892.1550
Classification Product Code
IYN  
Date Received11/05/1984
Decision Date 02/13/1985
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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