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FDA 510(k)

SULLIVAN HUMIDAIRE HEATED HUMIDIFIER

K-Number: K971260 · 1997-09-04

ApplicantResmed Corp
Decision Date1997-09-04
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SULLIVAN HUMIDAIRE HEATED HUMIDIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Resmed Corp. It received FDA 510(k) clearance on 1997-09-04 under 510(k) number K971260. 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 SULLIVAN HUMIDAIRE HEATED HUMIDIFIER?

SULLIVAN HUMIDAIRE HEATED HUMIDIFIER is a medical device that received FDA 510(k) clearance on 1997-09-04. The listed applicant is Resmed Corp. The 510(k) number is K971260.

When did SULLIVAN HUMIDAIRE HEATED HUMIDIFIER receive FDA 510(k) clearance?

SULLIVAN HUMIDAIRE HEATED HUMIDIFIER received FDA 510(k) clearance on 1997-09-04, under 510(k) number K971260.

Who is the listed applicant for SULLIVAN HUMIDAIRE HEATED HUMIDIFIER?

The FDA 510(k) record lists Resmed Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SULLIVAN HUMIDAIRE HEATED HUMIDIFIER?

The FDA product code for SULLIVAN HUMIDAIRE HEATED HUMIDIFIER is BTT.

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Related Devices (Code: 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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