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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
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