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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 K843376
Device Name ECG PATIENT MONITOR
Applicant
Rigel Medical Electronics, Inc.
250 Camino Alto
Mill Valley,  CA  94941
Applicant Contact MICHAEL E FEWER
Correspondent
Rigel Medical Electronics, Inc.
250 Camino Alto
Mill Valley,  CA  94941
Correspondent Contact MICHAEL E FEWER
Regulation Number870.2300
Classification Product Code
DRT  
Date Received08/28/1984
Decision Date 12/27/1984
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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