BiPAP Plus M-Series Bi-Level System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K061034 FDA 510(k)
- FDA Product Code
- BZD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5905 FDA 510(k)
- Regulation Number
- 868.5905 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BiPAP Plus M-Series Bi-Level System is a non-continuous ventilator that delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea (OSA) in spontaneously breathing patients weighing more than 66 lbs (30 kg). This device provides bi-level pressure support to help maintain airway patency during sleep.
The BiPAP Plus M-Series System is supplied as a complete system and is intended for single-patient use. It is not MRI safe and should be stored according to the manufacturer's instructions. The device has received FDA 510(k) clearance with the product code BZD and is classified as a Class II medical device under regulation number 868.5905.
Frequently asked questions
What is the BIPAP PLUS M-Series Bi-Level System used for?
The BIPAP PLUS M-Series Bi-Level System is a non-continuous ventilator that delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea (OSA) in spontaneously breathing patients weighing more than 66 lbs (30 kg).
How is the BIPAP PLUS M-Series System supplied and is it reusable?
The BiPAP Plus M-Series System is supplied as a complete system and is intended for single-patient use. It should not be shared between patients and should be stored according to the manufacturer's instructions.
What regulatory approvals does the BIPAP PLUS M-Series have?
The device has received FDA 510(k) clearance with the product code BZD and is classified as a Class II medical device under regulation number 868.5905. It is not MRI safe.
What are the specifications of the BIPAP PLUS M-Series System?
The BIPAP PLUS M-Series is a non-continuous ventilator that provides bi-level pressure support to help maintain airway patency during sleep. It is designed for spontaneously breathing patients weighing more than 66 lbs (30 kg).
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 PLUS USER MANUAL Pdf Download, Respironics BiPAP Plus M Series User Manual | Manualzz, RESPIRONICS M SERIES MANUAL Pdf Download | ManualsLib, BiPAP Plus M Series 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 | K061034 | Class II | Active |
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Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (1)
- FDA 510(k) K061034 24 fields · synced Oct 1, 2026