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Respironics, Inc.

United States·US-MF-000002301

Last updated September 17, 2026

Information

Country: United States
Address: 1001, Murry Ridge Lane, Murrysville, United States
Website: n/a
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: n/a
PRRC Contact: Melissa Rosko
EUDAMED SRN: US-MF-000002301
FDA FEI Number: 3007220521
DUNS Number: 080728314

Catalogue (3774)

Page 66 of 76

Device	Model / Reference	Registries	Class	Status
Rinoflow Micronized E.n.t. Wash System	K973875	FDA 510(k)	Class I	Active
SomnaPatch	K183625	FDA 510(k)	Class II	Active
Golox-93	K081779	FDA 510(k)	Class II	Active
Trilogy Evo Universal	K181170	FDA 510(k)	Class II	Active
Alice 5	K040595	FDA 510(k)	Class II	Active
Respironics Custom Ii Oral Appliance	K033823	FDA 510(k)	Class II	Active
Bageasy(r) Iii Adult Disposable Manual Resuscitator	K934310	FDA 510(k)	Class II	Active
Gel Mask	K954207	FDA 510(k)	Class II	Active
Bipap Synchrony	K063533	FDA 510(k)	Class II	Active
Stardust Ii, Model 1011176	K021845	FDA 510(k)	Class II	Active
AF531 Oro-Nasal SE Face Mask	K243394	FDA 510(k)	Class II	Active
Simple T Nasal Mask	K120145	FDA 510(k)	Class II	Active
Esprit Ventilator	K981072	FDA 510(k)	Class II	Active
Headstrap	K810991	FDA 510(k)	Class I	Active
Somnolyzer 24x7	K131994	FDA 510(k)	Class II	Active
Remstar Auto A-Flex Ht	K131982	FDA 510(k)	Class II	Active
Bipap S/T-D 30 System	K955324	FDA 510(k)	Class II	Active
Trilogy Evo	K181166	FDA 510(k)	Class II	Active
Total Face Mask	K925920	FDA 510(k)	Class II	Active
Bipap Synchrony 2	K092043	FDA 510(k)	Class II	Active
Actiheart	K052489	FDA 510(k)	Class II	Active
Vitalsense Xhr	K061870	FDA 510(k)	Class II	Active
Virtuoso Smart Cpap System	K953930	FDA 510(k)	Class II	Active
Bipap Avaps Ventilatory Support System	K102465	FDA 510(k)	Class II	Active
Respironics Total Face Mask	K992969	FDA 510(k)	Class II	Active
Trublue Nasal Mask	K110405	FDA 510(k)	Class II	Active
Millennium M10 Oxygen Concentrator, Model M10600; With Opi, Model M10605	K043006	FDA 510(k)	Class II	Active
Remstar Auto Cpap System	K012554	FDA 510(k)	Class II	Active
Respironics Remstar With Remote And Ramp	K911856	FDA 510(k)	Class II	Active
Sleepware G3	K202142	FDA 510(k)	Class II	Active
Respironics Monarch Mini Mask	K945938	FDA 510(k)	Class II	Active
Respironics Disposable Heated Wire Circuits	K110398	FDA 510(k)	Class II	Active
Sleepware G3	K142988	FDA 510(k)	Class II	Active
Wallaby 3 Phototherapy System, Model 3600	K991627	FDA 510(k)	Class II	Active
Respironics Infant Bageasy	K895351	FDA 510(k)	Class II	Active
Homelox	K081206	FDA 510(k)	Class II	Active
Remstar Plus Cpap System	K010263	FDA 510(k)	Class II	Active
Revolution Full Face Mask	K142554	FDA 510(k)	Class II	Active
Bageasy(r) Iii Child/Infant Dispos Man Resuscitators	K940581	FDA 510(k)	Class II	Active
Remstar Pro With C-Flex Cpap System	K021861	FDA 510(k)	Class II	Active
Therapy Mask 3100 NC/SP	K231313	FDA 510(k)	Class II	Active
Bipap Vision Ventilatory Support	K982454	FDA 510(k)	Class II	Active
Bipap Auto	K050759	FDA 510(k)	Class II	Active
Respironics Sleepeasy Nasal Cpap Sys	K843889	FDA 510(k)	Class II	Active
Bipap A 40 Ventilatory Support System	K121623	FDA 510(k)	Class II	Active
Whisper Swivel Ii Exhalation Port	K962203	FDA 510(k)	Class II	Active
Spectrum(tm) Mask	K936047	FDA 510(k)	Class II	Active
Bipap Pro Bi-Level System	K011714	FDA 510(k)	Class II	Active
Remstar Auto With C-Flex Cpap System	K041010	FDA 510(k)	Class II	Active
Modification To Remstar Auto Cpap System	K031460	FDA 510(k)	Class II	Active

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Respironics, Inc. Coyol Alajuela · CR FEI 3027553886