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510(k) K003067

CALEO by Drager Medizintechnik GmbH — Product Code FMZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2000
Date Received
October 2, 2000
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Incubator, Neonatal
Device Class
Class II
Regulation Number
880.5400
Review Panel
HO
Submission Type

Other clearances by Drager Medizintechnik GmbH

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  • K010793 — OXYLOG 1000, MODEL 2M86840 (December 20, 2001)
  • 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)
  • K984611 — DRAGER SOLA SERIES, MODELS 1000/700/500/300 (March 29, 1999)

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