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 IDK061426
510k NumberK061426
Device Name:OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47
ClassificationFilter, Bacterial, Breathing-circuit
Applicant POROUS MEDIA CORP. 1350 HAMMOND RD. St. Paul,  MN  55110
ContactDavid Rasch
CorrespondentDaniel W Lehtonen
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeCAH  
CFR Regulation Number868.5260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2006-05-23
Decision Date2006-06-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B462IVC11312490 K061426 000
B462252930015 K061426 000
B462DDF4799M03Y3 K061426 000
B462DDF4799M05Y3 K061426 000
B462DDF4799T100Y3 K061426 000
B462DFC0676M03NNV3 K061426 000
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10190752102330 K061426 000
10190752102323 K061426 000
B462DBF32K040 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
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10190752102309 K061426 000
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B46231743013 K061426 000
B4623690343003 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
B462DBH32K04TA5 K061426 000
B46250135001005 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
B462SF14385 K061426 000

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