FDA 510(k)

充填保持装置

K番号: K213773 · 2022-07-21

決定日2022-07-21

製品コードFDF

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

Insufflation Retention Device is the device name listed in this FDA 510(k) record. The listed applicant is Bpendo, LLC. It received FDA 510(k) clearance on 2022-07-21 under 510(k) number K213773. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Insufflation Retention Device?

Insufflation Retention Device is a medical device that received FDA 510(k) clearance on 2022-07-21. The listed applicant is Bpendo, LLC. The 510(k) number is K213773.

When did Insufflation Retention Device receive FDA 510(k) clearance?

Insufflation Retention Device received FDA 510(k) clearance on 2022-07-21, under 510(k) number K213773.

Who is the listed applicant for Insufflation Retention Device?

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

What is the FDA product code for Insufflation Retention Device?

The FDA product code for Insufflation Retention Device is FDF.

申請者としてBpendo, LLCを記載するその他の記録

K261587充填保持装置（IRD）（11173-325-101）

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