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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 989803178001 Microstream® EtCO2 Consumables CapnoLine® H O2 Infant/ Neonatal; 989803178021 Microstream® EtCO2 Consumables Nasal FilterLine Infant/Neonatal; 989803179101 Microstream® EtCO2 Consumables Nasal Filterline O2 Adult; 989803179111 Microstream® EtCO2 Consumables Nasal Filterline O2 Adult; 989803179121 Microstream® EtCO2 Consumables Filterline O2 Pediatric; 989803183071 Microstream® EtCO2 Consumables CapnoLine® H O2; M4681A Microstream® EtCO2 Consumables CapnoLine® H O2
Classification Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Product Code: CCK
Device Class: 2
Regulation Number: 868.1400
Medical Specialty: Anesthesiology
Registered Establishment Name: Philips North America LLC
Registered Establishment Number: 1218950
Premarket Submission Number: K010024
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Complaint File Establishment
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