FDA 510(k)

HumiGard手術用湿度調整システム、HumiGard加湿充填キット

K番号: K162582 · 2017-06-23

決定日2017-06-23

製品コードHIF

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OB [翻訳] OB

決定大幅同等

医療機器の概要

HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare. It received FDA 510(k) clearance on 2017-06-23 under 510(k) number K162582. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit?

HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit is a medical device that received FDA 510(k) clearance on 2017-06-23. The listed applicant is Fisher & Paykel Healthcare. The 510(k) number is K162582.

When did HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit receive FDA 510(k) clearance?

HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit received FDA 510(k) clearance on 2017-06-23, under 510(k) number K162582.

Who is the listed applicant for HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit?

The FDA 510(k) record lists Fisher & Paykel Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit?

The FDA product code for HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit is HIF.

申請者としてFisher & Paykel Healthcareを記載するその他の記録

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