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FDA 510(k)

HUMIDIFIER

K-Number: K945782 · 1996-03-01

ApplicantRespironics, Inc.
Decision Date1996-03-01
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HUMIDIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 1996-03-01 under 510(k) number K945782. 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 HUMIDIFIER?

HUMIDIFIER is a medical device that received FDA 510(k) clearance on 1996-03-01. The listed applicant is Respironics, Inc.. The 510(k) number is K945782.

When did HUMIDIFIER receive FDA 510(k) clearance?

HUMIDIFIER received FDA 510(k) clearance on 1996-03-01, under 510(k) number K945782.

Who is the listed applicant for HUMIDIFIER?

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

What is the FDA product code for HUMIDIFIER?

The FDA product code for 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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