Home / 510(k) Clearances / K981668

510(k) K981668

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1999
Date Received
May 11, 1998
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 Versamed , Ltd.

  • K021981 — IVENT 201 PORTABLE VENTILATOR (August 13, 2003)
  • K011957 — IVENT 201 PORTABLE VENTILATOR (July 18, 2001)

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