FDA.reportPublic FDA data

510(k) K023693

Device
MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100
Applicant
Airex, Inc.
510(k) number
K023693
Product code
FRF
Decision
Substantially Equivalent (SESE)
Decision date
2003-03-12
Date received
2002-11-01
Regulation
880.5045
Classification name
Cleaner, Air, Medical Recirculating
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
WILLIAM HASLEBACHER
Address
13704 SE 17th St. Bellevue WA US 98005 98005

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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