Transfer Container Humidifier

Q: What is the product code of K881648?

The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.

FDA 510(k) K881648 · Newport Biosystems, Inc.

Substantially Equivalent

510(k) numberK881648

Submission

Device name: Transfer Container Humidifier
Applicant: Newport Biosystems, Inc.
Redwood City, CA, US
Received: April 15, 1988
Decision date: December 30, 1988
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: CAF – Nebulizer (Direct Patient Interface)
Device class: Class II (moderate risk)
Regulation: 21 CFR 868.5630
Specialty: Anesthesiology

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More from Aerogen, Ltd.

510(k)	Device	Decision
K860282	Rpmi 1640 W/Glutamine W/HepesKIT · Traditional	02/05/1986SE
K855085	Tissue Culture MediaKIT · Traditional	01/13/1986SE
K853441	Fetal Bovine Serum in Transfer ContainerKJA · Traditional	08/26/1985SE

Questions and answers

When was Transfer Container Humidifier cleared by the FDA?

Transfer Container Humidifier (K881648) received a 510(k) decision of Substantially Equivalent on December 30, 1988, 259 days after the submission was received.

What is the product code of K881648?

The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.