FDA.report

510(k) K130153

Device
HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST
Applicant
PHILIPS MEDICAL SYSTEMS
510(k) number
K130153
Product code
MKJ  
Decision
Substantially Equivalent (SESE)
Decision date
2013-03-12
Date received
2013-01-22
Regulation
870.5310
Classification name
Automated External Defibrillators (non-wearable)
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
3
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
MARK PUOPOLO
Address
3000 Minuteman Rd. Andover MA US 01810 01810

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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