FDA.report

510(k) K843718

Device
PROGRAMMABLE STIMULATOR 5326
Applicant
MEDTRONIC VASCULAR
510(k) number
K843718
Product code
JOQ  
Decision
Substantially Equivalent (SESE)
Decision date
1984-09-27
Date received
1984-09-24
Regulation
870.1750
Classification name
Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only)
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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