FDA 510(k)

ホットドッグ温熱マットレス + リターン電極

K番号: K210727 · 2022-02-01

申請者Augustine Temperature Management, LLC

決定日2022-02-01

製品コードGEI

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

HotDog Warming Mattress + Return Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Augustine Temperature Management, LLC. It received FDA 510(k) clearance on 2022-02-01 under 510(k) number K210727. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the HotDog Warming Mattress + Return Electrode?

HotDog Warming Mattress + Return Electrode is a medical device that received FDA 510(k) clearance on 2022-02-01. The listed applicant is Augustine Temperature Management, LLC. The 510(k) number is K210727.

When did HotDog Warming Mattress + Return Electrode receive FDA 510(k) clearance?

HotDog Warming Mattress + Return Electrode received FDA 510(k) clearance on 2022-02-01, under 510(k) number K210727.

Who is the listed applicant for HotDog Warming Mattress + Return Electrode?

The FDA 510(k) record lists Augustine Temperature Management, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HotDog Warming Mattress + Return Electrode?

The FDA product code for HotDog Warming Mattress + Return Electrode is GEI.

申請者としてAugustine Temperature Management, LLCを記載するその他の記録

K232627ホットドッグ温熱マットレス + リターン電極 K230866ホットドッグ温熱マットレス + リターン電極

公式ソース

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