Oxygen Concentrator, Model JAY-5AW

FDA 510(k) K213210 · Longfian Scitech Co., Ltd.

Substantially Equivalent

510(k) numberK213210

Submission

Device name
Oxygen Concentrator, Model JAY-5AW
Applicant
Longfian Scitech Co., Ltd.
Baoding, CN
Received
September 29, 2021
Decision date
December 8, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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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More from Devilbiss Healthcare, LLC

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K243833Portable oxygen concentrator (JAY-1000P)CAW · Traditional 09/29/2025SE
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Questions and answers

When was Oxygen Concentrator, Model JAY-5AW cleared by the FDA?

Oxygen Concentrator, Model JAY-5AW (K213210) received a 510(k) decision of Substantially Equivalent on December 8, 2022, 435 days after the submission was received.

What is the product code of K213210?

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