Care ZY5BA Oxygen Concentrator

FDA 510(k) K102245 · Foshan Care Medical Technology Co., Ltd.

Substantially Equivalent

510(k) numberK102245

Submission

Device name
Care ZY5BA Oxygen Concentrator
Applicant
Foshan Care Medical Technology Co., Ltd.
Nanshan, Shenzhen, CN
Received
August 9, 2010
Decision date
November 9, 2010
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
CAW – Generator, Oxygen, Portable
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5440
Specialty
Anesthesiology

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Questions and answers

When was Care ZY5BA Oxygen Concentrator cleared by the FDA?

Care ZY5BA Oxygen Concentrator (K102245) received a 510(k) decision of Substantially Equivalent on November 9, 2010, 92 days after the submission was received.

What is the product code of K102245?

The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.