Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA PMA

VENTILATOR, HIGH FREQUENCY

PMA Number: P850064 · 2026-05-07

ApplicantBunnell, Inc.
Decision Date2026-05-07
PMA NumberP850064
Product CodeLSZ
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeAN

Device Summary

VENTILATOR, HIGH FREQUENCY is a medical device manufactured by Bunnell, Inc.. It received FDA Premarket Approval (PMA) on 2026-05-07 under PMA number P850064. The device is classified under FDA product code LSZ. It was reviewed by the AN advisory panel. This device is classified as Class III by the FDA. Class III devices subject to the most stringent regulatory controls. These devices generally require premarket approval (PMA) because they support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of U. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to submit clinical trial data demonstrating the safety and effectiveness of the device. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is VENTILATOR, HIGH FREQUENCY?

VENTILATOR, HIGH FREQUENCY is a medical device that received FDA Premarket Approval (PMA) on 2026-05-07. It is manufactured by Bunnell, Inc.. The PMA number is P850064.

When did VENTILATOR, HIGH FREQUENCY receive FDA PMA approval?

VENTILATOR, HIGH FREQUENCY received FDA PMA approval on 2026-05-07, under approval number P850064.

What company makes VENTILATOR, HIGH FREQUENCY?

VENTILATOR, HIGH FREQUENCY is manufactured by Bunnell, Inc..

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to provide clinical data proving safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for VENTILATOR, HIGH FREQUENCY?

The FDA product code for VENTILATOR, HIGH FREQUENCY is LSZ.

What FDA device class is VENTILATOR, HIGH FREQUENCY?

VENTILATOR, HIGH FREQUENCY is classified as Class III by the FDA.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑