FAILSAFE – PORTABLE INFECTION CONTROL SYSTEMS


Device Classification Name

chamber, patient isolation

510(k) Number K022260
Device Name FAILSAFE – PORTABLE INFECTION CONTROL SYSTEMS
Original Applicant
ISOLATION SYSTEMS, INC.
79 fillmore ave.
tonawanda, 
NY 
14150 -2335

Original Contact ted ulatowski
Regulation Number 880.5450
Classification Product Code
LGM  
Date Received 06/28/2002
Decision Date 08/29/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No