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510(k) K080141

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2008
Date Received
January 22, 2008
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)
  • K110463 — PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS) (November 10, 2011)
  • K012712 — NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 (May 8, 2002)
  • K000404 — PC ECG 1200 (November 22, 2000)

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