Home-Away System

FDA 510(k) K004047 · In-X Corp.

Substantially Equivalent

510(k) numberK004047

Submission

Device name
Home-Away System
Applicant
In-X Corp.
Denver, CO, US
Received
December 29, 2000
Decision date
December 18, 2001
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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K042944Home-Away System, Model 1041CAW · Traditional 04/15/2005SE
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Questions and answers

When was Home-Away System cleared by the FDA?

Home-Away System (K004047) received a 510(k) decision of Substantially Equivalent on December 18, 2001, 354 days after the submission was received.

What is the product code of K004047?

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