FDA 510(k)

Accordion Piccolo Stone Management Device

K番号: K172299 · 2017-09-19

申請者Ths International, Inc. D/B/A Accordion Medical

決定日2017-09-19

製品コードFFL

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定大幅同等

医療機器の概要

Accordion Piccolo Stone Management Device is the device name listed in this FDA 510(k) record. The listed applicant is Ths International, Inc. D/B/A Accordion Medical. It received FDA 510(k) clearance on 2017-09-19 under 510(k) number K172299. The device is classified under product code FFL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Accordion Piccolo Stone Management Device?

Accordion Piccolo Stone Management Device is a medical device that received FDA 510(k) clearance on 2017-09-19. The listed applicant is Ths International, Inc. D/B/A Accordion Medical. The 510(k) number is K172299.

When did Accordion Piccolo Stone Management Device receive FDA 510(k) clearance?

Accordion Piccolo Stone Management Device received FDA 510(k) clearance on 2017-09-19, under 510(k) number K172299.

Who is the listed applicant for Accordion Piccolo Stone Management Device?

The FDA 510(k) record lists Ths International, Inc. D/B/A Accordion Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Accordion Piccolo Stone Management Device?

The FDA product code for Accordion Piccolo Stone Management Device is FFL.

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Accordion Piccolo Stone Management Device

医療機器の概要

よくある質問

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