FDA 510(k)

HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit

K-번호: K162582 · 2017-06-23

결정일2017-06-23

제품 코드HIF

자문 위원회OB

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Fisher & Paykel Healthcare를 신청인으로 등재한 기타 기록

K222292F&P myAirvo 3 K220703F&P 950 Respiratory Humidifier K221338F&P Airvo 3 K162553AirSpiral Heated Breathing Tube

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