Patient Ventilation Oxygen Concentrating System, High Flow (Pvocs HF)

FDA 510(k) K051887 · Carleton Life Support Systems, Inc.

Substantially Equivalent

510(k) numberK051887

Submission

Device name
Patient Ventilation Oxygen Concentrating System, High Flow (Pvocs HF)
Applicant
Carleton Life Support Systems, Inc.
Davenport, IA, US
Received
July 12, 2005
Decision date
September 27, 2005
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 Patient Ventilation Oxygen Concentrating System, High Flow (Pvocs HF) cleared by the FDA?

Patient Ventilation Oxygen Concentrating System, High Flow (Pvocs HF) (K051887) received a 510(k) decision of Substantially Equivalent on September 27, 2005, 77 days after the submission was received.

What is the product code of K051887?

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