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510(k) K111487

NH-301 AMBULATORY ECG ANALYSIS SOFTWARE by Norav Medical Corp. — Product Code MLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2011
Date Received
May 31, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Norav Medical Corp.

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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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