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FDA PMA

呼吸器,高頻率

PMA 核准號:P850064 · 2026-05-07

申請人Bunnell, Inc.
決定日期2026-05-07
PMA 編號P850064
產品代碼LSZ
器械分類3 類
醫療專科U
諮詢委員會AN

器材摘要

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 2026-05-07. The device is classified under product code LSZ. It was reviewed by the AN advisory panel.

常見問題

What is the VENTILATOR, HIGH FREQUENCY?

VENTILATOR, HIGH FREQUENCY is a medical device that received FDA 510(k) clearance on 2026-05-07. 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.

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官方來源

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