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FDA PMA

VENTILATOR, HIGH FREQUENCY

PMA Number: P850064 · 2026-09-28

ApplicantBunnell, Inc.
Decision Date2026-09-28
PMA NumberP850064
Product CodeLSZ
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeAN

Device Summary

VENTILATOR, HIGH FREQUENCY is the device name listed in this FDA 510(k) record. The listed applicant is Bunnell, Inc.. It received FDA 510(k) clearance on 2026-09-28. The device is classified under product code LSZ. It was reviewed by the AN advisory panel.

Frequently Asked Questions

What is the VENTILATOR, HIGH FREQUENCY?

VENTILATOR, HIGH FREQUENCY is a medical device that received FDA 510(k) clearance on 2026-09-28. The listed applicant is Bunnell, Inc..

When did VENTILATOR, HIGH FREQUENCY receive FDA 510(k) clearance?

The clearance date for VENTILATOR, HIGH FREQUENCY can be found in the official FDA records.

Who is the listed applicant for VENTILATOR, HIGH FREQUENCY?

The FDA 510(k) record lists Bunnell, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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