C300 Series Air Nebulizer Compressor

Q: What is the product code of K062952?

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) K062952 · Choice Smart Health Care Co. , Ltd.

Substantially Equivalent

510(k) numberK062952

Submission

Device name: C300 Series Air Nebulizer Compressor
Applicant: Choice Smart Health Care Co. , Ltd.
Shanghai, CN
Received: September 29, 2006
Decision date: February 21, 2007
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA
Third-party review: Yes

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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Questions and answers

When was C300 Series Air Nebulizer Compressor cleared by the FDA?

C300 Series Air Nebulizer Compressor (K062952) received a 510(k) decision of Substantially Equivalent on February 21, 2007, 145 days after the submission was received.

What is the product code of K062952?

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