Patient Ventilation Oxygen Concentrating System (Pvocs)

FDA 510(k) K013223 · Litton Systems, Inc.

Substantially Equivalent

510(k) numberK013223

Submission

Device name
Patient Ventilation Oxygen Concentrating System (Pvocs)
Applicant
Litton Systems, Inc.
Davenport, IA, US
Received
September 27, 2001
Decision date
February 11, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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 Patient Ventilation Oxygen Concentrating System (Pvocs) cleared by the FDA?

Patient Ventilation Oxygen Concentrating System (Pvocs) (K013223) received a 510(k) decision of Substantially Equivalent on February 11, 2002, 137 days after the submission was received.

What is the product code of K013223?

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