Taga Velocity Humidifier

FDA 510(k) K031179 · Taga Medical Technologies, Inc.

Substantially Equivalent

510(k) numberK031179

Submission

Device name
Taga Velocity Humidifier
Applicant
Taga Medical Technologies, Inc.
Eastlake, OH, US
Received
April 15, 2003
Decision date
July 17, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 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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More from Medline Industries, LP

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K040507Taga Velocity Passover Humidifier with Heater, Model TM1000HBTT · Traditional 03/04/2004SE
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Questions and answers

When was Taga Velocity Humidifier cleared by the FDA?

Taga Velocity Humidifier (K031179) received a 510(k) decision of Substantially Equivalent on July 17, 2003, 93 days after the submission was received.

What is the product code of K031179?

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