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FDA 510(k)

RT019 INSPIRATORY/EXPIRATORY FILTER

K-Number: K050927 · 2005-08-01

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2005-08-01
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RT019 INSPIRATORY/EXPIRATORY FILTER 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 2005-08-01 under 510(k) number K050927. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RT019 INSPIRATORY/EXPIRATORY FILTER?

RT019 INSPIRATORY/EXPIRATORY FILTER is a medical device that received FDA 510(k) clearance on 2005-08-01. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K050927.

When did RT019 INSPIRATORY/EXPIRATORY FILTER receive FDA 510(k) clearance?

RT019 INSPIRATORY/EXPIRATORY FILTER received FDA 510(k) clearance on 2005-08-01, under 510(k) number K050927.

Who is the listed applicant for RT019 INSPIRATORY/EXPIRATORY FILTER?

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 RT019 INSPIRATORY/EXPIRATORY FILTER?

The FDA product code for RT019 INSPIRATORY/EXPIRATORY FILTER is CAH.

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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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