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510(k) K003068

SAVINA by Drager Medizintechnik GmbH — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2001
Date Received
October 2, 2000
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

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  • K012177 — VENTVIEW, MODEL 8414095 (September 4, 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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