FDA 510(k)

Atmo 氣囊系統

K 號：K250940 · 2025-06-26

決定日期2025-06-26

產品代碼NYV

諮詢委員會GU

決定相當於

器材摘要

Atmo Gas Capsule System is the device name listed in this FDA 510(k) record. The listed applicant is Atmo Biosciences, Ltd.. It received FDA 510(k) clearance on 2025-06-26 under 510(k) number K250940. The device is classified under product code NYV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Atmo Gas Capsule System?

Atmo Gas Capsule System is a medical device that received FDA 510(k) clearance on 2025-06-26. The listed applicant is Atmo Biosciences, Ltd.. The 510(k) number is K250940.

When did Atmo Gas Capsule System receive FDA 510(k) clearance?

Atmo Gas Capsule System received FDA 510(k) clearance on 2025-06-26, under 510(k) number K250940.

Who is the listed applicant for Atmo Gas Capsule System?

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

What is the FDA product code for Atmo Gas Capsule System?

The FDA product code for Atmo Gas Capsule System is NYV.

其他以 Atmo Biosciences, Ltd. 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。

K253569Atmo 氣囊系統

相關器械（代碼：NYV）

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。

K253569Atmo 氣囊系統Atmo Biosciences, Ltd.K250493MotiliCap 精準胃腸監測系統Anx Robotica Corporation

官方來源

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