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510(k) K011957

IVENT 201 PORTABLE VENTILATOR by Versamed , Ltd. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2001
Date Received
June 22, 2001
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 Versamed , Ltd.

  • K021981 — IVENT 201 PORTABLE VENTILATOR (August 13, 2003)
  • K981668 — SMARTVENT 201 PORTABLE VENTILATOR (April 7, 1999)

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