The following data is part of a premarket notification filed by Porous Media Corp. with the FDA for Oxygen Concentrator Filters, Models Dbf32, Dbf24, Dbf27, Dbf25, Dfc06 And Ddf47.
Device ID | K061426 |
510k Number | K061426 |
Device Name: | OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47 |
Classification | Filter, Bacterial, Breathing-circuit |
Applicant | POROUS MEDIA CORP. 1350 HAMMOND RD. St. Paul, MN 55110 |
Contact | David Rasch |
Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
Product Code | CAH |
CFR Regulation Number | 868.5260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2006-05-23 |
Decision Date | 2006-06-05 |
Summary: | summary |