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510(k) K012712

NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 by Norav Medical , Ltd. — Product Code MLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2002
Date Received
August 14, 2001
Clearance Type
Traditional
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

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