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PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRO — Philips Medical Systems (510(k) K1108

PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRO — Philips Medical Systems (510(k) K1108 is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRO; Applican

Device namePHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRO
ApplicantPhilips Medical Systems
Clearance track510(k)
Submission numberK110825
DecisionSubstantially Equivalent
Decision date2012-02-16
Date received2011-03-23
Product codeMKJ
Device class3
Medical specialtyCardiovascular
Applicant locationMA, US
SourceopenFDA device

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