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510(k) K081837

AVEA VENTILATOR by Cardinal Health 207, Inc. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2008
Date Received
June 30, 2008
Clearance Type
Special
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 Cardinal Health 207, Inc.

  • K093094 — VELA VENTILATOR (May 11, 2010)
  • K092484 — HELIOX LOW FLOW SENTRY BLENDER (April 2, 2010)
  • K093124 — PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, M (March 10, 2010)
  • K081670 — THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK (October 9, 2008)

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