FDA.report

510(k) K133534

Device
MCKESSON CARDIOLOGY ECG MOBILE
Applicant
MCKESSON ISRAEL LTD.
510(k) number
K133534
Product code
DQK  
Decision
Substantially Equivalent (SESE)
Decision date
2014-04-18
Date received
2013-11-18
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
PAUL SUMNER
Address
5995 Windward Pkwy. Alpharetta GA US 30005 30005

FDA Registration Numbers

Source Documents

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

Legacy Summary

summary

FDA Review

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