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510(k) K954828

ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT by Gibeck, Inc. — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1996
Date Received
October 20, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Gibeck, Inc.

  • K965016 — ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212) (December 2, 1997)
  • K964377 — THERMAL REGULATION SYSTEM BLANKET (April 23, 1997)
  • K964382 — HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(1940 (April 15, 1997)
  • K960511 — GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET (January 13, 1997)
  • K953544 — HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT (August 25, 1995)
  • K953491 — HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE (August 25, 1995)
  • K952845 — HUMID-VENT TRACH-VENT (July 25, 1995)
  • K952750 — HUMID-VENT 1 (July 20, 1995)
  • K952844 — HUMID-VENT 2 (July 20, 1995)
  • K952084 — HUMID-VENT FILTER PEDI (June 12, 1995)

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