Pogs, Model 33C

FDA 510(k) K063454 · On Site Gas Systems, Inc.

Substantially Equivalent

510(k) numberK063454

Submission

Device name
Pogs, Model 33C
Applicant
On Site Gas Systems, Inc.
Newington, CT, US
Received
November 15, 2006
Decision date
May 9, 2007
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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K092636Pogs, Model 65/130CAW · Traditional 01/07/2010SE
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K030920Pogs 33CAW · Traditional 03/10/2004SE
K021581HemosorbQSY · Traditional 07/12/2002SE
K013390QuickclotQSY · Traditional 05/23/2002SE
K021082On Site Gas Systems Portable Oxygen Generation SYSTEM-1.0 and 5.0CAW · Traditional 05/22/2002SE
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Questions and answers

When was Pogs, Model 33C cleared by the FDA?

Pogs, Model 33C (K063454) received a 510(k) decision of Substantially Equivalent on May 9, 2007, 175 days after the submission was received.

What is the product code of K063454?

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