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FDA 510(k)

MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER

K-Number: K881970 · 1989-03-09

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date1989-03-09
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER 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 1989-03-09 under 510(k) number K881970. 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 MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER?

MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER is a medical device that received FDA 510(k) clearance on 1989-03-09. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K881970.

When did MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER receive FDA 510(k) clearance?

MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER received FDA 510(k) clearance on 1989-03-09, under 510(k) number K881970.

Who is the listed applicant for MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER?

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 MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER?

The FDA product code for MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER is BTT.

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Other records listing Fisher & Paykel Healthcare, Ltd. as applicant

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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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