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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 989803160271 Microstream® EtCO2 Consumables Smart CapnoLine® O2 Long; 989803177951 Microstream® EtCO2 Consumables Smart CapnoLine® H O2 Adult; 989803177961 Microstream® EtCO2 Consumables Smart CapnoLine® H 02 Adult Long; 989803177971 Microstream® EtCO2 Consumables Smart CapnoLine® H 02 Pediatric; 989803177981 Microstream® EtCO2 Consumables Smart CapnoLine® H O2 Pediatric Long; 989803182951 Microstream® EtCO2 Consumables Smart CapnoLine® O2 Pediatric; 989803182961 Microstream® EtCO2 Consumables Smart CapnoLine® O2 Adult; 989803182971 Microstream® EtCO2 Consumables Smart CapnoLine® H O2 Adult; 989803182981 Microstream® EtCO2 Consumables Smart CapnoLine® O2 Long,Adult
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: K011536
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Complaint File Establishment
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