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Sign in to claim this brandRespironics, 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
- —
- —
- [email protected]
- Phone
- n/a
- PRRC Contact
- Melissa Rosko
- EUDAMED SRN
- US-MF-000002301
- FDA FEI Number
- 3007220521
- DUNS Number
- 080728314
Catalogue (3774)
Page 67 of 76| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bipap Synchrony Ventilatory Support System With Bi-Flex | K020777 | FDA 510(k) | Class II | Active |
| Sapphire | K152356 | FDA 510(k) | Class II | Active |
| Rinoflow Micronized E.n..t. Wash Sytstem | K963550 | FDA 510(k) | Class I | Active |
| Bipap Synchrony 2 With Af531 Full Face Mask | K101130 | FDA 510(k) | Class II | Active |
| Esprit Ventilator With Af531 Se Full Face Mask | K101129 | FDA 510(k) | Class II | Active |
| Respironics Vacuvest Respiratory Support System | K895849 | FDA 510(k) | Class II | Active |
| Espirt | K001208 | FDA 510(k) | Class II | Active |
| Respironics Suctioneasy | K882017 | FDA 510(k) | Class I | Active |
| Respironics Bipap Remote Control Unit | K905540 | FDA 510(k) | Class II | Active |
| Bipap Model S/T-D | K951264 | FDA 510(k) | Class II | Active |
| V60 Ventilator With Ppv And Auto-Trak+ Software Options | K102985 | FDA 510(k) | Class II | Active |
| Stardust Ii | K052573 | FDA 510(k) | Class II | Active |
| Bipap Duet System | K964363 | FDA 510(k) | Class II | Active |
| Hayek Oscillator, Modification | K921726 | FDA 510(k) | Class II | Active |
| Care Orchestrator | K181053 | FDA 510(k) | Class II | Active |
| Kangaroo Nasal Mask | K122847 | FDA 510(k) | Class II | Active |
| Respironics' Digital Manometer | K904935 | FDA 510(k) | Class II | Active |
| Simplygo Portable Oxygen Concentrator | K111885 | FDA 510(k) | Class II | Active |
| Bipap Pro 2 Bi-Level System | K032834 | FDA 510(k) | Class II | Active |
| Remview Sleep Recorder, Model 320 | K003499 | FDA 510(k) | Class II | Active |
| Simple T Pediatric Nasal Mask | K151120 | FDA 510(k) | Class II | Active |
| Bipap A 30 Ventilatory Support System | K113053 | FDA 510(k) | Class II | Active |
| Nasal/Oral Mask | K925587 | FDA 510(k) | Class II | Active |
| Respironics Endo Tube Control Sys | K822794 | FDA 510(k) | Class I | Active |
| Omni 5 Total O2 Delivery System | K091028 | FDA 510(k) | Class II | Active |
| Heel Snuggler, Model 99047 | K040044 | FDA 510(k) | Class I | Active |
| Maestro Clinical Remote Control | K954572 | FDA 510(k) | Class II | Active |
| Respironics Silhouette Nasal Mask, Models 1003224 And 1003223 | K000705 | FDA 510(k) | Class II | Active |
| Performax Pediatric Ee Total Face Mask | K120562 | FDA 510(k) | Class II | Active |
| Bilichek Non-Invasive Bilirubin Analyzer | K983071 | FDA 510(k) | Class I | Active |
| Smartmonitor 2ps | K061256 | FDA 510(k) | Class II | Active |
| Pressure Valve | K963250 | FDA 510(k) | Class II | Active |
| AF541 EE Full Face Mask | K150639 | FDA 510(k) | Class II | Active |
| Smartrecorder, Model 2500 | K990199 | FDA 510(k) | Class II | Active |
| Coughassist T70 Device | K121955 | FDA 510(k) | Class II | Active |
| Sander's Maskcpap By Respironics | K851396 | FDA 510(k) | Class II | Active |
| Esprit Ventilator, Model V1000 | K034040 | FDA 510(k) | Class II | Active |
| L4 Oxygen Concentrator | K061261 | FDA 510(k) | Class II | Active |
| Golife Nasal Mask | K110008 | FDA 510(k) | Class II | Active |
| Respironics Vent Easy Oxygen Enrichme | K842605 | FDA 510(k) | Class I | Active |
| Eocd | K041568 | FDA 510(k) | Class II | Active |
| Respironics Secureasy | K860845 | FDA 510(k) | Class I | Active |
| Bipap Harmony Ventilatory Support System | K031656 | FDA 510(k) | Class II | Active |
| Ti Nasal Mask | K140980 | FDA 510(k) | Class II | Active |
| Spectrum 2 Reusable Full Face Mask, Model 1004884 And 1004876 | K002465 | FDA 510(k) | Class II | Active |
| Modified Sanders Bi-Papeasy | K883825 | FDA 510(k) | Class II | Active |
| Exercise Ecg Electrodes, Reusable | K821384 | FDA 510(k) | Class II | Active |
| Bipap Synchrony Ventilatory Support System | K012323 | FDA 510(k) | Class II | Active |
| Golife Nasal Mask | K102502 | FDA 510(k) | Class II | Active |
| AF541 SE Full Face Mask | K150638 | 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