FDA 510(k)

Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS

K番号: K222608 · 2022-12-16

決定日2022-12-16

製品コードFLE

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS is the device name listed in this FDA 510(k) record. The listed applicant is Tuttnauer , Ltd.. It received FDA 510(k) clearance on 2022-12-16 under 510(k) number K222608. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS?

Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS is a medical device that received FDA 510(k) clearance on 2022-12-16. The listed applicant is Tuttnauer , Ltd.. The 510(k) number is K222608.

When did Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS receive FDA 510(k) clearance?

Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS received FDA 510(k) clearance on 2022-12-16, under 510(k) number K222608.

Who is the listed applicant for Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS?

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

What is the FDA product code for Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS?

The FDA product code for Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS is FLE.

申請者としてTuttnauer , Ltd.を記載するその他の記録

K221227Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 K213080T-エッジ10、T-エッジ11 K181456Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 および 69180 殺菌器

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