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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: 989803194631, Expression MR IBP DPT Kit, A/P, Box 20; 989803194641, Expression MR IBP DPT Kit, I/N, Box 20; TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT
Classification Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
Product Code: DRS
Device Class: 2
Regulation Number: 870.2850
Medical Specialty: Cardiovascular
Registered Establishment Name: Philips Electronics Ltd
Registered Establishment Number: 3000126629
Premarket Submission Number: K061573
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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