FDA 510(k)

MotiliCap 精準胃腸監測系統

K 號：K250493 · 2025-05-21

決定日期2025-05-21

產品代碼NYV

諮詢委員會GU

決定相當於

器材摘要

MotiliCap GI Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Anx Robotica Corporation. It received FDA 510(k) clearance on 2025-05-21 under 510(k) number K250493. 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 MotiliCap GI Monitoring System?

MotiliCap GI Monitoring System is a medical device that received FDA 510(k) clearance on 2025-05-21. The listed applicant is Anx Robotica Corporation. The 510(k) number is K250493.

When did MotiliCap GI Monitoring System receive FDA 510(k) clearance?

MotiliCap GI Monitoring System received FDA 510(k) clearance on 2025-05-21, under 510(k) number K250493.

Who is the listed applicant for MotiliCap GI Monitoring System?

The FDA 510(k) record lists Anx Robotica Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MotiliCap GI Monitoring System?

The FDA product code for MotiliCap GI Monitoring System is NYV.

其他以 Anx Robotica Corporation 為申請人之記錄

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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.K250940Atmo 氣囊系統Atmo Biosciences, Ltd.

官方來源

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