510(k) K071526

UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV by Impact Instrumentation, Inc. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2008
Date Received
June 4, 2007
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