FDA 510(k)

ストルス・メディカルドゥオリスSD1 T-トッパー & タワー・システムに C-アクターセピア・ハンドピース

K番号: K202112 · 2021-02-21

決定日2021-02-21

製品コードPZL

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

Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Storz Medical AG. It received FDA 510(k) clearance on 2021-02-21 under 510(k) number K202112. The device is classified under product code PZL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece?

Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece is a medical device that received FDA 510(k) clearance on 2021-02-21. The listed applicant is Storz Medical AG. The 510(k) number is K202112.

When did Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece receive FDA 510(k) clearance?

Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece received FDA 510(k) clearance on 2021-02-21, under 510(k) number K202112.

Who is the listed applicant for Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece?

The FDA 510(k) record lists Storz Medical AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece?

The FDA product code for Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece is PZL.

申請者としてStorz Medical AGを記載するその他の記録

K203710ストルス・メディカルマグネトライス・マッスル・スティミュレーター K173692D-Actor 200 振動マッサージシステム

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