Travelsome Standard

FDA 510(k) K030233 · Sim Italia S.R.L.

Substantially Equivalent

510(k) numberK030233

Submission

Device name
Travelsome Standard
Applicant
Sim Italia S.R.L.
Great Neck, NY, US
Received
January 23, 2003
Decision date
April 25, 2003
Decision
Substantially Equivalent (SESE)
Type
Special 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 Travelsome Standard cleared by the FDA?

Travelsome Standard (K030233) received a 510(k) decision of Substantially Equivalent on April 25, 2003, 92 days after the submission was received.

What is the product code of K030233?

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