HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A

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 Heartstreamfr2 Aed With M3848a And M3849a, Models M3860a, M3861, M3840a, M3841a.

Pre-market Notification Details

Device IDK014157
510k NumberK014157
Device Name:HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A
ClassificationAutomated External Defibrillators (non-wearable)
Applicant PHILIPS MEDICAL SYSTEMS 2401 FOURTH AVE., SUITE 500 Seattle,  WA  98121
ContactTamara Yount
CorrespondentTamara Yount
PHILIPS MEDICAL SYSTEMS 2401 FOURTH AVE., SUITE 500 Seattle,  WA  98121
Product CodeMKJ  
CFR Regulation Number870.5310 [🔎]
DecisionSe Subject To Tracking Reg (ST)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-12-19
Decision Date2002-01-17
Summary:summary

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