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FDA 510(k)

RESPIRATORY HUMIDIFER

K-Number: K110019 · 2012-03-30

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2012-03-30
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRATORY HUMIDIFER is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2012-03-30 under 510(k) number K110019. 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 RESPIRATORY HUMIDIFER?

RESPIRATORY HUMIDIFER is a medical device that received FDA 510(k) clearance on 2012-03-30. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K110019.

When did RESPIRATORY HUMIDIFER receive FDA 510(k) clearance?

RESPIRATORY HUMIDIFER received FDA 510(k) clearance on 2012-03-30, under 510(k) number K110019.

Who is the listed applicant for RESPIRATORY HUMIDIFER?

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

What is the FDA product code for RESPIRATORY HUMIDIFER?

The FDA product code for RESPIRATORY HUMIDIFER 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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