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510(k) K000404

PC ECG 1200 by Norav Medical , Ltd. — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2000
Date Received
February 7, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Norav Medical , Ltd.

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  • K080141 — PC ECG 1200W SYSTEM (April 25, 2008)
  • K012712 — NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 (May 8, 2002)

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