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510(k) K133534

MCKESSON CARDIOLOGY ECG MOBILE by Mckesson Israel , Ltd. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2014
Date Received
November 18, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

Other clearances by Mckesson Israel , Ltd.

  • K151850 — McKesson Cardiology (August 11, 2015)
  • K131497 — MCKESSON CARDIOLOGY HEMO (December 5, 2013)
  • K113515 — HORIZON CARDIOLOGY ECG MANAGEMENT (March 16, 2012)
  • K112720 — MCKESSON HORIZON CARDIOLOGY (January 30, 2012)

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