FDA 510(k)

Aqua Medical RF Vapor System

K番号: K183595 · 2019-06-21

決定日2019-06-21

製品コードKNS

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

Aqua Medical RF Vapor System is the device name listed in this FDA 510(k) record. The listed applicant is Aqua Medical, Inc.. It received FDA 510(k) clearance on 2019-06-21 under 510(k) number K183595. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Aqua Medical RF Vapor System?

Aqua Medical RF Vapor System is a medical device that received FDA 510(k) clearance on 2019-06-21. The listed applicant is Aqua Medical, Inc.. The 510(k) number is K183595.

When did Aqua Medical RF Vapor System receive FDA 510(k) clearance?

Aqua Medical RF Vapor System received FDA 510(k) clearance on 2019-06-21, under 510(k) number K183595.

Who is the listed applicant for Aqua Medical RF Vapor System?

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

What is the FDA product code for Aqua Medical RF Vapor System?

The FDA product code for Aqua Medical RF Vapor System is KNS.

申請者としてAqua Medical, Inc.を記載するその他の記録

K251226Aqua Medical RF Vapor Ablation System K241271Aqua Medical RF Vapor Ablation System K213627RF蒸気システム K211282Aqua Medical RF Vapor System

公式ソース

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