Longfian Oxygen Concentrator

FDA 510(k) K131968 · Longfian Scitech Co., Ltd.

Substantially Equivalent

510(k) numberK131968

Submission

Device name
Longfian Oxygen Concentrator
Applicant
Longfian Scitech Co., Ltd.
Miami, FL, US
Received
June 28, 2013
Decision date
September 5, 2014
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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Questions and answers

When was Longfian Oxygen Concentrator cleared by the FDA?

Longfian Oxygen Concentrator (K131968) received a 510(k) decision of Substantially Equivalent on September 5, 2014, 434 days after the submission was received.

What is the product code of K131968?

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