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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 K842037
Device Name LS 5
Applicant
Life Science Instrumentation, Inc.
10150 SW Nimbus Ave. E-7
Portland,  OR  97223
Applicant Contact WILLIAM H FLEMING
Correspondent
Life Science Instrumentation, Inc.
10150 SW Nimbus Ave. E-7
Portland,  OR  97223
Correspondent Contact WILLIAM H FLEMING
Regulation Number870.2300
Classification Product Code
DRT  
Date Received05/11/1984
Decision Date 03/01/1985
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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