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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: NIVO or NIVO Pro Nebulizer; NIVO Pro Nebulizer w/EE or SE Elbow
Classification Name: NEBULIZER (DIRECT PATIENT INTERFACE)
Product Code: CAF
Device Class: 2
Regulation Number: 868.5630
Medical Specialty: Anesthesiology
Registered Establishment Name: Philips Electronics Ltd
Registered Establishment Number: 3000126629
Premarket Submission Number: K102240
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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