FDA.report

510(k) K113515

Device
HORIZON CARDIOLOGY ECG MANAGEMENT
Applicant
MCKESSON ISRAEL LTD.
510(k) number
K113515
Product code
DQK  
Decision
Substantially Equivalent (SESE)
Decision date
2012-03-16
Date received
2011-11-28
Regulation
870.1425
Classification name
Computer, Diagnostic, Programmable
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
TOMER LEVY
Address
Hanechoshet 4 Tel Aviv IL 69710 69710

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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17540262110098Change Healthcare Cardiology ECG Management Change Healthcare Canada Company2022-02-28
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17540262110043Change Healthcare Cardiology ECG ManagementChange Healthcare Canada Company2020-08-23
17540262110036Change Healthcare Cardiology ECG ManagementChange Healthcare Canada Company2019-08-26
17540262110029Change Healthcare Cardiology ECG ManagementCHANGE HEALTHCARE ISRAEL LTD2018-11-22
17540262110012Change Healthcare Cardiology ECG ManagementCHANGE HEALTHCARE ISRAEL LTD2018-08-20
80010939040028McKesson Cardiology ECG ManagementMCKESSON TECHNOLOGIES INC.2017-03-09

Legacy Summary

summary

FDA Review

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