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FDA 510(k)

HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit

K-Number: K162582 · 2017-06-23

ApplicantFisher & Paykel Healthcare
Decision Date2017-06-23
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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