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510(k) K030341

MODIFICATION TO INSPIRATION VENTILATOR SYSTEM by eVent Medical, Ltd. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2004
Date Received
February 3, 2003
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.

  • K130178 — INSPIRATION VENTILATOR SYSTEM 5I/7I (October 29, 2013)
  • 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)
  • K021112 — INSPIRATION VENTILATOR SYSTEM (November 22, 2002)

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