Horizon Cardiology ECG Management

FDA 510(k) K113515 · Mckesson Israel , Ltd.

Substantially Equivalent

510(k) numberK113515

Submission

Device name
Horizon Cardiology ECG Management
Applicant
Mckesson Israel , Ltd.
Tel Aviv, IL
Received
November 28, 2011
Decision date
March 16, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DQK – Computer, Diagnostic, Programmable
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1425
Specialty
Cardiovascular

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Questions and answers

When was Horizon Cardiology ECG Management cleared by the FDA?

Horizon Cardiology ECG Management (K113515) received a 510(k) decision of Substantially Equivalent on March 16, 2012, 109 days after the submission was received.

What is the product code of K113515?

The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.