FDA 510(k)

INTAI手術用マスク（非滅菌）

K番号: K210422 · 2022-03-30

決定日2022-03-30

製品コードFXX

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

INTAI Surgical Mask (non-sterile) is the device name listed in this FDA 510(k) record. The listed applicant is Intai Technology Corp.. It received FDA 510(k) clearance on 2022-03-30 under 510(k) number K210422. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the INTAI Surgical Mask (non-sterile)?

INTAI Surgical Mask (non-sterile) is a medical device that received FDA 510(k) clearance on 2022-03-30. The listed applicant is Intai Technology Corp.. The 510(k) number is K210422.

When did INTAI Surgical Mask (non-sterile) receive FDA 510(k) clearance?

INTAI Surgical Mask (non-sterile) received FDA 510(k) clearance on 2022-03-30, under 510(k) number K210422.

Who is the listed applicant for INTAI Surgical Mask (non-sterile)?

The FDA 510(k) record lists Intai Technology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTAI Surgical Mask (non-sterile)?

The FDA product code for INTAI Surgical Mask (non-sterile) is FXX.

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INTAI手術用マスク（非滅菌）

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：FXX）

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