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FDA 510(k)

MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100

K-Number: K023693 · 2003-03-12

ApplicantAirex, Inc.
Decision Date2003-03-12
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100 is the device name listed in this FDA 510(k) record. The listed applicant is Airex, Inc.. It received FDA 510(k) clearance on 2003-03-12 under 510(k) number K023693. The device is classified under product code FRF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100?

MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100 is a medical device that received FDA 510(k) clearance on 2003-03-12. The listed applicant is Airex, Inc.. The 510(k) number is K023693.

When did MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100 receive FDA 510(k) clearance?

MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100 received FDA 510(k) clearance on 2003-03-12, under 510(k) number K023693.

Who is the listed applicant for MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100?

The FDA 510(k) record lists Airex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100?

The FDA product code for MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100 is FRF.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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