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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K932929
Device Name HRV 4000EM
Applicant
All-Tronics Medical Systems
3289 E. 55th St.
Cleveland,  OH  44127
Applicant Contact DENNIS E ALTHAR
Correspondent
All-Tronics Medical Systems
3289 E. 55th St.
Cleveland,  OH  44127
Correspondent Contact DENNIS E ALTHAR
Regulation Number870.2800
Classification Product Code
DSH  
Date Received06/15/1993
Decision Date 09/09/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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