CerroZone Mobile

FDA 510(k) K220298 · Cerrozone

Substantially Equivalent

510(k) numberK220298

Submission

Device name
CerroZone Mobile
Applicant
Cerrozone
St. Louis, MO, US
Received
February 2, 2022
Decision date
July 1, 2022
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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More from Air Innovations, Inc.

510(k)DeviceDecision
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Questions and answers

When was CerroZone Mobile cleared by the FDA?

CerroZone Mobile (K220298) received a 510(k) decision of Substantially Equivalent on July 1, 2022, 149 days after the submission was received.

What is the product code of K220298?

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