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FDA 510(k)

HUMIDAIRE 2I

K-Number: K080797 · 2008-07-09

ApplicantResmed, Ltd.
Decision Date2008-07-09
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HUMIDAIRE 2I is the device name listed in this FDA 510(k) record. The listed applicant is Resmed, Ltd.. It received FDA 510(k) clearance on 2008-07-09 under 510(k) number K080797. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMIDAIRE 2I?

HUMIDAIRE 2I is a medical device that received FDA 510(k) clearance on 2008-07-09. The listed applicant is Resmed, Ltd.. The 510(k) number is K080797.

When did HUMIDAIRE 2I receive FDA 510(k) clearance?

HUMIDAIRE 2I received FDA 510(k) clearance on 2008-07-09, under 510(k) number K080797.

Who is the listed applicant for HUMIDAIRE 2I?

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

What is the FDA product code for HUMIDAIRE 2I?

The FDA product code for HUMIDAIRE 2I is BTT.

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Official Source

View on FDA Database →

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

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