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510(k) K113743

EVOLUTION 3E VENTILATOR by Event Medical, Inc. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2012
Date Received
December 20, 2011
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 Event Medical, Inc.

  • K130178 — INSPIRATION VENTILATOR SYSTEM 5I/7I (October 29, 2013)
  • K072590 — INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM A (January 4, 2008)
  • K051550 — INSPIRATION VENTILATOR SYSTEM (July 12, 2005)
  • K040220 — MEDICAL AIR COMPRESSOR (June 9, 2004)
  • K030341 — MODIFICATION TO INSPIRATION VENTILATOR SYSTEM (January 16, 2004)
  • K021112 — INSPIRATION VENTILATOR SYSTEM (November 22, 2002)

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