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FDA 510(k)

MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU

K-Number: K033710 · 2004-04-13

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2004-04-13
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU 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 2004-04-13 under 510(k) number K033710. 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 MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU?

MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU is a medical device that received FDA 510(k) clearance on 2004-04-13. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K033710.

When did MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU receive FDA 510(k) clearance?

MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU received FDA 510(k) clearance on 2004-04-13, under 510(k) number K033710.

Who is the listed applicant for MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU?

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 MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU?

The FDA product code for MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU 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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