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510(k) K023289

OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072 by Drager Medizintechnik GmbH — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2003
Date Received
October 2, 2002
Clearance Type
Special
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

Other clearances by Drager Medizintechnik GmbH

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  • K012177 — VENTVIEW, MODEL 8414095 (September 4, 2001)
  • K003068 — SAVINA (June 25, 2001)
  • K010093 — NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474 (June 14, 2001)
  • K010724 — SOLA 700,SOLA 500, SOLA 300 (June 7, 2001)
  • K003067 — CALEO (December 13, 2000)
  • K984611 — DRAGER SOLA SERIES, MODELS 1000/700/500/300 (March 29, 1999)

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