OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47

Filter, Bacterial, Breathing-circuit

POROUS MEDIA CORP.

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.

Pre-market Notification Details

• 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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B462DBF32K040	K061426	000
B462252930015	K061426	000
B462DDF4799M03Y3	K061426	000
B462DDF4799M05Y3	K061426	000
B462DDF4799T100Y3	K061426	000
B462DFC0676M03NNV3	K061426	000
B462DDF4700M02C3	K061426	000
B46200080020435	K061426	000
B462017006113	K061426	000
B4621000610003	K061426	000
B4621006629203	K061426	000
B4621020510003	K061426	000
B46210783153	K061426	000
B46211312495	K061426	000
B4621990603	K061426	000
10190752102347	K061426	000
10190752102330	K061426	000
B462DDF4700M02C0	K061426	000
B462DDF4700M03Y0	K061426	000
B462DDF4711T100K0	K061426	000
B462DDF4711T100Y0	K061426	000
B462DDF4739T100Y0	K061426	000
B462DDF4700M02Y0	K061426	000
B4624150010000	K061426	000
B462DDF4700T100C0	K061426	000
B462TAGSF14380	K061426	000
10190752101968	K061426	000
10190752102293	K061426	000
10190752102309	K061426	000
10190752102316	K061426	000
10190752102323	K061426	000
B46231743013	K061426	000
B4623690343003	K061426	000
B46250135001005	K061426	000
B462DDF47115	K061426	000
B462DDF4711M03YFJ3	K061426	000
B462DDF47995	K061426	000
B462DDF4799M03YPM3	K061426	000
B462DFC0622M03YSC5	K061426	000
B462DFC0699M03YTM5	K061426	000
B462DFC06DV5	K061426	000
B462FBF14385	K061426	000
B462FBF316143	K061426	000
B462FBF3818MPT3	K061426	000
B462HLTH5203	K061426	000
B462IBFP5	K061426	000
B462INVFILTER5	K061426	000
B462P0750X0303	K061426	000
B462DDF4700M02YHM3	K061426	000
B462DDF4700M02YHF3	K061426	000
B4625056535	K061426	000
B4626411085	K061426	000
B4626411305	K061426	000
B46275037175	K061426	000
B462762575	K061426	000
B4627700015	K061426	000
B46286727H015	K061426	000
B46287200065	K061426	000
B462BMP1733	K061426	000
B462DBF325	K061426	000
B462DBF32K04BU5	K061426	000
B462DBF32K04FD5	K061426	000
B462DBF32K04FJ5	K061426	000
B462DBH32K04TA5	K061426	000
B462SF14385	K061426	000