Taga Velocity Passover Humidifier with Heater, Model TM1000H

FDA 510(k) K040507 · Taga Medical Technologies, Inc.

Substantially Equivalent

510(k) numberK040507

Submission

Device name
Taga Velocity Passover Humidifier with Heater, Model TM1000H
Applicant
Taga Medical Technologies, Inc.
Eastlake, OH, US
Received
February 27, 2004
Decision date
March 4, 2004
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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Questions and answers

When was Taga Velocity Passover Humidifier with Heater, Model TM1000H cleared by the FDA?

Taga Velocity Passover Humidifier with Heater, Model TM1000H (K040507) received a 510(k) decision of Substantially Equivalent on March 4, 2004, 6 days after the submission was received.

What is the product code of K040507?

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