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510(k) K072885

CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110 by Draeger Medical AG & Co. KG — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2008
Date Received
October 9, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

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  • 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)
  • K072002 — FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55 (January 31, 2008)

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