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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K834600
Device Name RECOMB ECG PREAMPLIFIER/206 069 03
Applicant
LITTON MEDICAL ELECTRONICS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
LITTON MEDICAL ELECTRONICS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.2300
Classification Product Code
DRT  
Date Received12/30/1983
Decision Date 06/01/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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