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510(k) K072002

FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55 by Draeger Medical AG & Co. KG — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2008
Date Received
July 23, 2007
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 Draeger Medical AG & Co. KG

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  • K092029 — VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 (August 6, 2010)
  • K100941 — INFINITY MCABLE - MAINSTREAM CO2 (April 23, 2010)
  • K092999 — NBP CUFF (November 24, 2009)
  • K083050 — EVITE XL (December 29, 2008)
  • K081447 — FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO (October 8, 2008)
  • K081743 — CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS (September 22, 2008)
  • K072884 — FABIUS MRI (July 30, 2008)
  • K072885 — CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110 (April 7, 2008)

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  • K221836 — Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus (December 7, 2022)
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  • K210352 — GGM Breathing Circuit Bacterial Filter (March 27, 2022)
  • K211286 — Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger (November 16, 2021)
  • K202459 — Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-H (September 26, 2021)