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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K061426
Device Name OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47
Applicant
Porous Media Corp.
1350 Hammond Rd.
St. Paul,  MN  55110
Applicant Contact DAVID RASCH
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number868.5260
Classification Product Code
CAH  
Date Received05/23/2006
Decision Date 06/05/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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