FDA.report

510(k) K061905

Device
HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0
Applicant
MEDCON LTD.
510(k) number
K061905
Product code
DQK  
Decision
Substantially Equivalent (SESE)
Decision date
2006-11-08
Date received
2006-07-05
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
JONATHAN S KAHAN
Address
555 Thirteenth St. NW Washington DC US 20004 20004

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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