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FDA 510(k)

BREAS HA50 HUMIDIFIER, MODEL HA50

K-Number: K002454 · 2001-03-07

ApplicantVital Signs, Inc.
Decision Date2001-03-07
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BREAS HA50 HUMIDIFIER, MODEL HA50 is the device name listed in this FDA 510(k) record. The listed applicant is Vital Signs, Inc.. It received FDA 510(k) clearance on 2001-03-07 under 510(k) number K002454. 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 BREAS HA50 HUMIDIFIER, MODEL HA50?

BREAS HA50 HUMIDIFIER, MODEL HA50 is a medical device that received FDA 510(k) clearance on 2001-03-07. The listed applicant is Vital Signs, Inc.. The 510(k) number is K002454.

When did BREAS HA50 HUMIDIFIER, MODEL HA50 receive FDA 510(k) clearance?

BREAS HA50 HUMIDIFIER, MODEL HA50 received FDA 510(k) clearance on 2001-03-07, under 510(k) number K002454.

Who is the listed applicant for BREAS HA50 HUMIDIFIER, MODEL HA50?

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

What is the FDA product code for BREAS HA50 HUMIDIFIER, MODEL HA50?

The FDA product code for BREAS HA50 HUMIDIFIER, MODEL HA50 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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