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510(k) K110463

PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS) by Norav Medical , Ltd. — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2011
Date Received
February 17, 2011
Clearance Type
Special
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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  • K111487 — NH-301 AMBULATORY ECG ANALYSIS SOFTWARE (November 10, 2011)
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  • K012712 — NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 (May 8, 2002)
  • K000404 — PC ECG 1200 (November 22, 2000)

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