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Model APT 1010 Ultrahigh Frequency Ventilator

FDA PMA

Class III (US FDA PMA)

PMA P890034

by Covidien

Identity

Trade Name
MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR FDA PMA
Generic Name
VENTILATOR, HIGH FREQUENCY FDA PMA

Identifiers

PMA Number
P890034 FDA PMA
FDA Product Code
LSZ FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Anesthesiology FDA PMA
FDA Decision
APWD FDA PMA

The Model APT 1010 Ultrahigh Frequency Ventilator is a high-frequency ventilator designed for respiratory support. It is classified as a Ventilator, High Frequency under generic nomenclature.

This device is manufactured by Covidien and received FDA PMA authorization (P890034) on December 13, 1991. It is intended for use in clinical settings requiring high-frequency ventilation therapy.

Frequently asked questions

What type of ventilator is the Model APT 1010?

The Model APT 1010 is classified as a high-frequency ventilator, specifically a Ventilator, High Frequency, based on its generic name and device classification in the provided data.

Who manufactures the Model APT 1010 Ultrahigh Frequency Ventilator?

The Model APT 1010 Ultrahigh Frequency Ventilator is manufactured by Covidien, as stated in the manufacturer and applicant fields of the device data.

What regulatory authorization does the Model APT 1010 have?

The Model APT 1010 has FDA PMA authorization, with the PMA number P890034, as indicated in the AUTHORIZATIONS and pma_number fields.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Covidien

Sources (1)

  • FDA PMA P890034 23 fields · synced Sep 18, 2026