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510(k) K062091

POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION by Porous Media Corp. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2006
Date Received
July 24, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type

Other clearances by Porous Media Corp.

  • K061426 — OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47 (June 5, 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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