FDA 510(k), K051263, EVITAXL WITH OPTION SMARTCARE

FDA 510(k), K051263, EVITAXL WITH OPTION SMARTCARE

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510(K) Number: K051263
Device Name: EVITAXL WITH OPTION SMARTCARE
Manufacturer: DRAGER MEDICAL AG & CO. KGAA
Device Classification Name: Ventilator, Continuous, Facility Use
Regulation Number: 868.5895
Classification Product Code: CBK
Date Received: 05/16/2005
Decision Date: 07/12/2005
Regulation Medical Specialty: Anesthesiology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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