Conchatherm 2000 Humidification System, Models 500-00, -10, -20, -30, -40, -50, & -60

Q: What is the product code of K001213?

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) K001213 · Hudson Respiratory Care, Inc.

Substantially Equivalent

510(k) numberK001213

Submission

Device name: Conchatherm 2000 Humidification System, Models 500-00, -10, -20, -30, -40, -50, & -60
Applicant: Hudson Respiratory Care, Inc.
Temecula, CA, US
Received: April 14, 2000
Decision date: November 3, 2000
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 Conchatherm 2000 Humidification System, Models 500-00, -10, -20, -30, -40, -50, & -60 cleared by the FDA?

Conchatherm 2000 Humidification System, Models 500-00, -10, -20, -30, -40, -50, & -60 (K001213) received a 510(k) decision of Substantially Equivalent on November 3, 2000, 203 days after the submission was received.

What is the product code of K001213?

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