Rugged Oxygen Generator (ROG) (RO01-00001)

FDA 510(k) K240561 · Molecular Products , Ltd.

Substantially Equivalent

510(k) numberK240561

Submission

Device name
Rugged Oxygen Generator (ROG) (RO01-00001)
Applicant
Molecular Products , Ltd.
Harlow Essex, GB
Received
February 29, 2024
Decision date
December 6, 2024
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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K131016RogsCAW · Special 11/27/2013SE
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Questions and answers

When was Rugged Oxygen Generator (ROG) (RO01-00001) cleared by the FDA?

Rugged Oxygen Generator (ROG) (RO01-00001) (K240561) received a 510(k) decision of Substantially Equivalent on December 6, 2024, 281 days after the submission was received.

What is the product code of K240561?

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