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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: 989803160301 Microstream® EtCO2 Consumables Smart CapnoLine Plus Long
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: K011050
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Complaint File Establishment
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