Aquapak 020 Humidifier Adapter

Q: What is the product code of K833974?

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) K833974 · Respiratory Care, Inc.

Substantially Equivalent

510(k) numberK833974

Submission

Device name: Aquapak 020 Humidifier Adapter
Applicant: Respiratory Care, Inc.
Walker, MI, US
Received: November 16, 1983
Decision date: December 16, 1983
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

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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K241778	Hudson RCI Comfort Flo® CubCannulaBTT · Traditional	Medline Industries, LP	12/19/2024SE
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More from Medline Industries, LP

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K892230	Rci Viral/Bacterial FilterCAH · Traditional	08/28/1989SE
K884150	Modified Conchatherm III Controlled HeaterBTT · Traditional	11/21/1988SE
K881625	Conchatherm III Plus Dual Heat Wire Servo ControllBZE · Traditional	06/21/1988SE
K864147	AquavalveBYH · Traditional	12/05/1986SE
K863955	Colby Level AlarmBTT · Traditional	11/07/1986SE
K861555	Circapak Universal Volume Ventilator CircuitBZD · Traditional	06/05/1986SE
K834151	Conchatherm LHF Humidifier HeaterBTT · Traditional	01/13/1984SE
K832453	Slimb Single Limb Breathing CircuitCAI · Traditional	10/27/1983SE
K811524	AquacadeLHC · Traditional	07/01/1981SE
K811073	A QuapakBTT · Traditional	04/29/1981SE

Questions and answers

When was Aquapak 020 Humidifier Adapter cleared by the FDA?

Aquapak 020 Humidifier Adapter (K833974) received a 510(k) decision of Substantially Equivalent on December 16, 1983, 30 days after the submission was received.

What is the product code of K833974?

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