MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100


Device Classification Name

cleaner, air, medical recirculating

510(k) Number K023693
Device Name MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100
Original Applicant
AIREX INC.
13704 s.e. 17th st.
bellevue, 
WA 
98005

Original Contact william haslebacher
Regulation Number 880.5045
Classification Product Code
FRF  
Date Received 11/01/2002
Decision Date 03/12/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No