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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 K855125
Device Name PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEM
Applicant
Honeywell, Inc.
One Campus Dr.
Pleasantville,  NY  10570
Applicant Contact MARTIN KUTIK
Correspondent
Honeywell, Inc.
One Campus Dr.
Pleasantville,  NY  10570
Correspondent Contact MARTIN KUTIK
Regulation Number870.2300
Classification Product Code
DRT  
Date Received12/23/1985
Decision Date 03/26/1986
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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