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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: M5066A HeartStart Onsite Defibrillator; M5068A HeartStart Home Defibrillator; M5070A Primary Battery; M5071A Adult SMART Pads Cartridge; M5072A Infant/Child SMART Pads Cartridge
Classification Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Product Code: MKJ
Device Class: 3
Regulation Number: 870.5310
Medical Specialty: Cardiovascular
Registered Establishment Name: Philips Electronics Ltd
Registered Establishment Number: 3000126629
Premarket Submission Number: P160029
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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