FDA 510(k)

AVEA可抛弃式呼氣過濾器/水鎖 (11790)

K 號：K251133 · 2025-05-08

決定日期2025-05-08

產品代碼CBK

諮詢委員會AN

決定相當於

器材摘要

AVEA disposable expiratory filter/water trap (11790) is the device name listed in this FDA 510(k) record. The listed applicant is Telesair, Inc.. It received FDA 510(k) clearance on 2025-05-08 under 510(k) number K251133. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AVEA disposable expiratory filter/water trap (11790)?

AVEA disposable expiratory filter/water trap (11790) is a medical device that received FDA 510(k) clearance on 2025-05-08. The listed applicant is Telesair, Inc.. The 510(k) number is K251133.

When did AVEA disposable expiratory filter/water trap (11790) receive FDA 510(k) clearance?

AVEA disposable expiratory filter/water trap (11790) received FDA 510(k) clearance on 2025-05-08, under 510(k) number K251133.

Who is the listed applicant for AVEA disposable expiratory filter/water trap (11790)?

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

What is the FDA product code for AVEA disposable expiratory filter/water trap (11790)?

The FDA product code for AVEA disposable expiratory filter/water trap (11790) is CBK.

其他以 Telesair, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K223863邦華呼吸濕化器

相關器械（代碼：CBK）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253647Evita (V800)；Evita (V600)Draegerwerk AG & CO Kgaa K252663Inbentus 多功能Iconic Solutions by Murcia, SL K251888VPAP兒童臉部口罩Hsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV醫院通氣全臉罩，適用單肢循環 – 尺寸A (ONIV117A)；F&P OptiNIV醫院通氣全臉罩，適用單肢循環 – 尺寸B (ONIV117B)；F&P OptiNIV醫院通氣全臉罩，適用單肢循環 – 尺寸C (ONIV117C)；F&P OptiNIV ONIV117-F醫院通氣全臉罩，可選配呼氣過濾器，適用單肢循環 - 尺寸A (ONIV117A-F)；F&P OptiNIV ONIV117-F醫院通氣全臉罩Fisher & Paykel Healthcare, Ltd.K243767SV600、SV800 呼吸器Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

官方來源

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