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FDA 510(k)

RESPIRATORY HUMIDIFIER, MODEL MR850

K-Number: K073706 · 2008-03-31

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2008-03-31
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRATORY HUMIDIFIER, MODEL MR850 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 2008-03-31 under 510(k) number K073706. 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 HUMIDIFIER, MODEL MR850?

RESPIRATORY HUMIDIFIER, MODEL MR850 is a medical device that received FDA 510(k) clearance on 2008-03-31. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K073706.

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

RESPIRATORY HUMIDIFIER, MODEL MR850 received FDA 510(k) clearance on 2008-03-31, under 510(k) number K073706.

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

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 HUMIDIFIER, MODEL MR850?

The FDA product code for RESPIRATORY HUMIDIFIER, MODEL MR850 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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