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Plv Continuum Ventilator, Model P1000

FDA 510(k)

Class II (US FDA 510(k))

510(k) K022750

by Respironics California, Inc.

Identifiers

510(k) Number
K022750 FDA 510(k)
FDA Product Code
NOU 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 Plv Continuum Ventilator, Model P1000 is a microprocessor-controlled, compressor-based mechanical ventilator that delivers room air to patients via invasive or non-invasive interfaces. It utilizes an internal compressor to generate compressed air, with breath delivery managed by software algorithms. The device features a membrane keypad and LED indicators for setting selection and alarm monitoring.

The Plv Continuum Ventilator, Model P1000 is intended for use in home, institutional, and portable settings, providing continuous or intermittent ventilatory support for pediatric and adult patients weighing at least 5 kg. The device is supplied with an FDA 510K authorization and is classified under regulation number 868.5895. It is a continuous ventilator for home use, with a product code of NOU.

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: PLV CONTINUUM VENTILATOR, MODEL P1000 - Innolitics, Plv Continuum Ventilator, Model P1000 510 (k) FDA Premarket ..., fda.innolitics.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Respironics California, Inc.

Sources (1)

  • FDA 510(k) K022750 24 fields · synced Sep 22, 2026