American Bantex Humidifier, Dry, Bubble, Models B9000, 3 Psi and B9100, 6 Psi

Q: What is the product code of K041963?

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

FDA 510(k) K041963 · American Bantex Corp.

Substantially Equivalent

510(k) numberK041963

Submission

Device name: American Bantex Humidifier, Dry, Bubble, Models B9000, 3 Psi and B9100, 6 Psi
Applicant: American Bantex Corp.
Bountiful, UT, US
Received: July 21, 2004
Decision date: October 20, 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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Questions and answers

When was American Bantex Humidifier, Dry, Bubble, Models B9000, 3 Psi and B9100, 6 Psi cleared by the FDA?

American Bantex Humidifier, Dry, Bubble, Models B9000, 3 Psi and B9100, 6 Psi (K041963) received a 510(k) decision of Substantially Equivalent on October 20, 2004, 91 days after the submission was received.

What is the product code of K041963?

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