Foshan Care Medical Nebulizer Model KYWH2001

Q: What is the product code of K101552?

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) K101552 · Foshan Care Medical Technology Co., Ltd.

Substantially Equivalent

510(k) numberK101552

Submission

Device name: Foshan Care Medical Nebulizer Model KYWH2001
Applicant: Foshan Care Medical Technology Co., Ltd.
Carmichael, CA, US
Received: June 4, 2010
Decision date: March 14, 2011
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

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 Foshan Care Medical Nebulizer Model KYWH2001 cleared by the FDA?

Foshan Care Medical Nebulizer Model KYWH2001 (K101552) received a 510(k) decision of Substantially Equivalent on March 14, 2011, 283 days after the submission was received.

What is the product code of K101552?

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