Breas HA50 Humidifier, Model HA50

FDA 510(k) K002454 · Vital Signs, Inc.

Substantially Equivalent

510(k) numberK002454

Submission

Device name
Breas HA50 Humidifier, Model HA50
Applicant
Vital Signs, Inc.
Englewood, CO, US
Received
August 10, 2000
Decision date
March 7, 2001
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BTT – Humidifier, Respiratory Gas, (Direct Patient Interface)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5450
Specialty
Anesthesiology

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Questions and answers

When was Breas HA50 Humidifier, Model HA50 cleared by the FDA?

Breas HA50 Humidifier, Model HA50 (K002454) received a 510(k) decision of Substantially Equivalent on March 7, 2001, 209 days after the submission was received.

What is the product code of K002454?

The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.