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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: IRMA CO2 Measurement Device; ISA CO2 Measurement Device; Masimo O3 Measurement Device; PHILIPS Masimo CO2 Module; PHILIPS Masimo O3 Module
Classification Name: COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
Product Code: DXG
Device Class: 2
Regulation Number: 870.1435
Medical Specialty: Cardiovascular
Registered Establishment Name: Philips Electronics Ltd
Registered Establishment Number: 3000126629
Premarket Submission Number: K192137
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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