Identifiers
- 510(k) Number
- K951264 FDA 510(k)
- FDA Product Code
- MNT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5895 FDA 510(k)
- Regulation Number
- 868.5895 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BiPAP Model S/T-D is a Sv70 Ventilator device classified under the Anesthesiology medical specialty. It is a bilevel positive airway pressure ventilatory support system designed for noninvasive ventilation.
This device received FDA 510(k) clearance (K951264) on July 29, 1996, and is manufactured by Respironics, Inc. It is a Class II medical device intended for use in clinical settings as a ventilatory support system.
Frequently asked questions
What is the BiPAP Model S/T-D used for?
The BiPAP Model S/T-D is a bilevel positive airway pressure ventilatory support system designed for noninvasive ventilation, intended for use in clinical settings to assist patients with breathing.
Who manufactures the BiPAP Model S/T-D and when was it cleared?
The BiPAP Model S/T-D is manufactured by Respironics, Inc. and received FDA 510(k) clearance (K951264) on July 29, 1996, as a substantially equivalent device under the Anesthesiology specialty.
What regulatory classification does the BiPAP Model S/T-D have?
The BiPAP Model S/T-D is classified as a Class II medical device under the Sv70 Ventilator category, with product code MNT and regulation number 868.5895, based on its FDA 510(k) submission.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: RESPIRONICS BIPAP S/T USER MANUAL Pdf Download, Respironics BiPAP S/T-D Manuals | ManualsLib, Philips Respironics BiPAP S / S/T / S-D / S/T-D User Manual, PDF Designed with patients in mind - Philips, Respironics BiPAP S/T Ventilatory Support System Clinical Manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K951264 | Class II | Active |
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Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (1)
- FDA 510(k) K951264 24 fields · synced Sep 26, 2026