PZ-800 Volume Ventilator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K822835 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K822749 Active Cleared 6 Oct 1982

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  FDA 510(k) K830654 Active Cleared 24 Mar 1983

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• Pilling Lacrimal Intubation System(Ster.

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  FDA 510(k) K822747 Active Cleared 18 Oct 1982

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• What is the PZ-800 Volume Ventilator used for?

  The PZ-800 Volume Ventilator is designed for sustained mechanical ventilation in facility-based settings, such as hospitals or surgical suites. It provides controlled volumes of oxygen and air to patients requiring assisted or full respiratory support, particularly in critical care or operating room environments where precise gas flow and pressure regulation are essential.

• Is the PZ-800 Volume Ventilator reusable or single-use?

  The PZ-800 Volume Ventilator is a reusable facility-use device. It is intended for installation in healthcare settings and requires proper cleaning, maintenance, and calibration to ensure reliable operation. Unlike single-use devices, it is not sterile at shipment and must be processed between patients according to manufacturer instructions.

• What regulatory approval does the PZ-800 Volume Ventilator hold?

  The PZ-800 Volume Ventilator has received FDA 510(k) clearance (K822835) under regulation 868.5895, with a decision of Substantially Equivalent (SESE) by the Anesthesiology Advisory Committee. This classification places it as a Class II medical device, adhering to special controls for ventilator safety and performance as outlined by the FDA.

• How should the PZ-800 Volume Ventilator be stored and handled?

  The PZ-800 Volume Ventilator follows standard facility protocols for reusable medical equipment. Storage and handling should comply with healthcare facility guidelines to maintain its functionality. Since it is not sterile at shipment, it must undergo proper cleaning, maintenance, and calibration before use to ensure safe and effective operation.

• Can the PZ-800 Volume Ventilator be used in MRI environments?

  The available data does not specify compliance with MRI safety standards for the PZ-800 Volume Ventilator. Therefore, its use is restricted to non-MRI environments unless validated for such applications by the manufacturer or through additional testing.