Portable Oxygen Generator System

FDA 510(k) K062153 · Molecular Products , Ltd.

Substantially Equivalent

510(k) numberK062153

Submission

Device name
Portable Oxygen Generator System
Applicant
Molecular Products , Ltd.
Bonita Springs, FL, US
Received
July 27, 2006
Decision date
November 21, 2006
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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Questions and answers

When was Portable Oxygen Generator System cleared by the FDA?

Portable Oxygen Generator System (K062153) received a 510(k) decision of Substantially Equivalent on November 21, 2006, 117 days after the submission was received.

What is the product code of K062153?

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