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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: IntelliVue M1026B Anesthetic Gas Module
Classification Name: PH RATE MEASUREMENT, CARBON-DIOXIDE
Product Code: JFL
Device Class: 2
Regulation Number: 862.1160
Medical Specialty: Clinical Chemistry
Registered Establishment Name: Philips Electronics Ltd
Registered Establishment Number: 3000126629
Premarket Submission Number: K040971
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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