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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Philips HeartStart FR3 AED Models 861388 (Text) and 861389 (ECG)
Classification Name: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
Product Code: LDD
Device Class: 2
Regulation Number: 870.5300
Medical Specialty: Cardiovascular
Registered Establishment Name: Philips Electronics Ltd
Registered Establishment Number: 3000126629
Premarket Submission Number: K130684
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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