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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Coated Cuff; M4550A Cuff Adapter; M4551A Cuff Y-adapter; M4560A Cuff adapter; M4561A Cuff Y-adapter; M4570A Cuff adapter; M4571A Cuff Y-adapter; M4590A Cuff Adapter for Single Hose Cuffs; M4591A Cuff Adapter for Single Hose Cuffs; M4592A Cuff Adapter for Two Hose Cuffs; M4593A Cuff Adapter for Two Hose Cuffs; M4594A Y cuff Adapter for Two Hose Cuffs; M4595A Y Cuff Adapter for Two Hose Cuffs; M4596A Y Cuff Adapter for Two Hose Cuffs
Classification Name: BLOOD PRESSURE CUFF
Product Code: DXQ
Device Class: 2
Regulation Number: 870.1120
Medical Specialty: Cardiovascular
Registered Establishment Name: Philips Electronics Ltd
Registered Establishment Number: 3000126629
Premarket Submission Number: K884421
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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