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BiPAP Pro 2 Bi-Level System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K032834

by Respironics, Inc.

Identifiers

510(k) Number
K032834 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 Pro 2 Bi-Level System is a non-continuous ventilator designed to deliver positive airway pressure therapy. It is indicated for the treatment of Obstructive Sleep Apnea in spontaneously breathing adult patients weighing over 30kg.

This device is authorized for use in both home and hospital or institutional environments. It is regulated under FDA 510(k) clearance, and users should refer to the provided user manual for specific operational and storage instructions.

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 pro 2 & plus User Manual | Manualzz, BIPAP PRO 2 BI-LEVEL SYSTEM (K032834) - FDA 510 (k), BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX - fda.innolitics.com, PDF BiPAP Pro Bi-Flex USER MANUAL - documents.philips.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Respironics, Inc.

Sources (1)

  • FDA 510(k) K032834 24 fields · synced Sep 22, 2026