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510(k) K072590

INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEM by Event Medical, Inc. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2008
Date Received
September 14, 2007
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)
  • K113743 — EVOLUTION 3E VENTILATOR (December 18, 2012)
  • 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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