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510(k) K010093

NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474 by Drager Medizintechnik GmbH — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2001
Date Received
January 11, 2001
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

Other clearances by Drager Medizintechnik GmbH

  • K023289 — OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072 (January 15, 2003)
  • K010793 — OXYLOG 1000, MODEL 2M86840 (December 20, 2001)
  • K012177 — VENTVIEW, MODEL 8414095 (September 4, 2001)
  • K003068 — SAVINA (June 25, 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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