Innosan Travelair S Portable Oxygen Concentrator, Code No. M407001853

FDA 510(k) K963042 · Sim Italia S.R.L.

Substantially Equivalent

510(k) numberK963042

Submission

Device name
Innosan Travelair S Portable Oxygen Concentrator, Code No. M407001853
Applicant
Sim Italia S.R.L.
Great Neck,, NY, US
Received
August 5, 1996
Decision date
November 1, 1996
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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K030233Travelsome StandardCAW · Special 04/25/2003SE
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Questions and answers

When was Innosan Travelair S Portable Oxygen Concentrator, Code No. M407001853 cleared by the FDA?

Innosan Travelair S Portable Oxygen Concentrator, Code No. M407001853 (K963042) received a 510(k) decision of Substantially Equivalent on November 1, 1996, 88 days after the submission was received.

What is the product code of K963042?

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