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510(k) K042108

VISTA PLUS by Novacor — Product Code MLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2005
Date Received
August 4, 2004
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

Other clearances by Novacor

  • K040753 — R-TEST EVOLUTION 3 (June 10, 2004)

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