Sullivan Humidaire Heated Humidifier

Q: What is the product code of K971260?

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) K971260 · Resmed Corp

Substantially Equivalent

510(k) numberK971260

Submission

Device name: Sullivan Humidaire Heated Humidifier
Applicant: Resmed Corp
San Diego, CA, US
Received: April 4, 1997
Decision date: September 4, 1997
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement 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 Sullivan Humidaire Heated Humidifier cleared by the FDA?

Sullivan Humidaire Heated Humidifier (K971260) received a 510(k) decision of Substantially Equivalent on September 4, 1997, 153 days after the submission was received.

What is the product code of K971260?

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