Identifiers
- 510(k) Number
- K063540 FDA 510(k)
- FDA Product Code
- MNS 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 device is a continuous, non-life-supporting ventilator classified under device class 2. It is identified as a ventilator, continuous, non-life-supporting in the device name field and is associated with the medical specialty of anesthesiology.
It received FDA 510(k) clearance under K063540 on February 22, 2007, as substantially equivalent via an abbreviated review process. The device is manufactured by Respironics, Inc. and is supplied for use in accordance with healthcare professional prescriptions, with no indication of sterility, single-use status, MRI safety, sizes, or storage conditions provided in the data.
Frequently asked questions
What is the BIPAP AUTOSV used for?
The BIPAP AUTOSV is a continuous, non-life-supporting ventilator intended for use in the medical specialty of anesthesiology, as indicated in its FDA 510(k) clearance documentation, and is supplied for use according to healthcare professional prescriptions.
Is the BIPAP AUTOSV sterile or single-use?
The device data does not indicate whether the BIPAP AUTOSV is sterile or single-use; no information about sterility, single-use status, or reprocessing is provided in the authorization or specifications.
What sizes or models are available for the BIPAP AUTOSV?
The device data does not specify any sizes, models, or variations for the BIPAP AUTOSV; only the device name 'BIPAP AUTOSV' and its associated K063540 clearance are provided.
How should the BIPAP AUTOSV be stored?
No storage conditions are specified in the device data; the information provided does not include any details about temperature, humidity, or other storage requirements for the BIPAP AUTOSV.
What regulatory pathway was used for the BIPAP AUTOSV?
The BIPAP AUTOSV received FDA 510(k) clearance under K063540 on February 22, 2007, through an abbreviated review process, and was found substantially equivalent to a predicate device.
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: PDF Clinical update of BiPAP autoSV for treatment of Sleep ... - Philips, Philips - DreamStation BiPAP autoSV Servo-ventilation system, PDF BiPAP autoSV User manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K063540 | Class II | Active |
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Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (1)
- FDA 510(k) K063540 24 fields · synced Sep 22, 2026