HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A

Automated External Defibrillators (non-wearable)

PHILIPS MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Heartstream Xl Defibrillator/monitor, Model #m4735a.

Pre-market Notification Details

Device IDK021453
510k NumberK021453
Device Name:HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A
ClassificationAutomated External Defibrillators (non-wearable)
Applicant PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover,  MA  01810
ContactRichard J Petersen
CorrespondentRichard J Petersen
PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover,  MA  01810
Product CodeMKJ  
CFR Regulation Number870.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-06
Decision Date2002-07-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838003354 K021453 000
00884838003347 K021453 000
00884838003330 K021453 000
00884838003323 K021453 000
00884838002760 K021453 000
00884838002111 K021453 000
00884838002104 K021453 000
00884838002098 K021453 000
00884838002081 K021453 000

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