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510(k) K130178

INSPIRATION VENTILATOR SYSTEM 5I/7I by eVent Medical, Ltd. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2013
Date Received
January 25, 2013
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, Ltd.

  • K113743 — EVOLUTION 3E VENTILATOR (December 18, 2012)
  • 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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