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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 K894919
Device Name NR5000 E.C.G. AND PULSE OXIMETER MONITOR
Applicant
Nirad , Ltd.
Enkalon Industrial Estate
25 Randlestown Rd.
Antrim Co. Antrim,  IE BT41 4LJ
Applicant Contact ANDREW O'HARA
Correspondent
Nirad , Ltd.
Enkalon Industrial Estate
25 Randlestown Rd.
Antrim Co. Antrim,  IE BT41 4LJ
Correspondent Contact ANDREW O'HARA
Regulation Number870.2300
Classification Product Code
DRT  
Date Received08/02/1989
Decision Date 09/18/1989
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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