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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: VM4 Monitor w/NIBP, SpO2, ECG, Ptemp; VM6 Monitor w/NIBP, SpO2, ECG, Continuous temp; VM6 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temp; VM8 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temperature, 10¿ Display; VM8 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temperature, etCO2, 10¿ Display; VM8 SE w/ NIBP, SpO2, ECG, IBP, Continuous temperature, etCO2, 10¿ Display; VM8 SE w/NIBP, SpO2, ECG, IBP, Continuous temperature, 10¿ Display
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: K123900
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Complaint File Establishment
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