FDA 510(k)

オーキッドセーフティリリースバルブ™

K番号: K241415 · 2024-09-06

決定日2024-09-06

製品コードQOI

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Substantially Equivalent

医療機器の概要

Orchid Safety Release Valve™ is the device name listed in this FDA 510(k) record. The listed applicant is Linear Health Sciences, LLC. It received FDA 510(k) clearance on 2024-09-06 under 510(k) number K241415. The device is classified under product code QOI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Orchid Safety Release Valve™?

Orchid Safety Release Valve™ is a medical device that received FDA 510(k) clearance on 2024-09-06. The listed applicant is Linear Health Sciences, LLC. The 510(k) number is K241415.

When did Orchid Safety Release Valve™ receive FDA 510(k) clearance?

Orchid Safety Release Valve™ received FDA 510(k) clearance on 2024-09-06, under 510(k) number K241415.

Who is the listed applicant for Orchid Safety Release Valve™?

The FDA 510(k) record lists Linear Health Sciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Orchid Safety Release Valve™?

The FDA product code for Orchid Safety Release Valve™ is QOI.

申請者としてLinear Health Sciences, LLCを記載するその他の記録

K232094オーキッドセーフティリリースバルブ™K230266オーキッドセーフティリリースバルブ K212064オーキッドセーフティリリースバルブ™

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。