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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: BiPAP autoSV ADV w/Hum 30cm (RIST); BiPAP autoSV Advanced; DreamStation BiPAP autoSV w/ & w/o Humidifier; DreamStation BiPAP AVAPS w/ & w/o Humidifier; DreamStation BiPAP S/T w/ & w/o Humidifier; Omnilab Advanced/Advanced +; Omnilab Direct; PC Direct; System One BiPAP w/ & w/o Humidifier; System One CPAP w/ & w/o Humidifier
Classification Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
Product Code: MNS
Device Class: 2
Regulation Number: 868.5895
Medical Specialty: Anesthesiology
Registered Establishment Name: Philips Electronics Ltd
Registered Establishment Number: 3000126629
Premarket Submission Number: K090539
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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