Mobile Particulate Contamination Control System, Model M-100

FDA 510(k) K023693 · Airex, Inc.

Substantially Equivalent

510(k) numberK023693

Submission

Device name
Mobile Particulate Contamination Control System, Model M-100
Applicant
Airex, Inc.
Bellevue, WA, US
Received
November 1, 2002
Decision date
March 12, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FRF – Cleaner, Air, Medical Recirculating
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5045
Specialty
General Hospital

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Questions and answers

When was Mobile Particulate Contamination Control System, Model M-100 cleared by the FDA?

Mobile Particulate Contamination Control System, Model M-100 (K023693) received a 510(k) decision of Substantially Equivalent on March 12, 2003, 131 days after the submission was received.

What is the product code of K023693?

The FDA product code is FRF – Cleaner, Air, Medical Recirculating, a Class II (moderate risk) device regulated under 21 CFR 880.5045.