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510(k) K061426

OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47 by Porous Media Corp. — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2006
Date Received
May 23, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type

Other clearances by Porous Media Corp.

  • K062091 — POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION (August 8, 2006)
  • K990276 — POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER (October 1, 1999)
  • K982385 — POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER (February 1, 1999)
  • K982127 — POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER (June 23, 1998)
  • K965020 — POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER (March 14, 1997)
  • K964979 — POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER (March 11, 1997)
  • K952428 — POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTER (July 7, 1995)
  • K934132 — POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER (October 4, 1994)

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