510(k) K072214

PORTABLE VENTILATOR, MODEL EPV-100 by Allied Healthcare Products, Inc. — Product Code BTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2008
Date Received
August 9, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Powered (Resuscitator)
Device Class
Class II
Regulation Number
868.5925
Review Panel
AN
Submission Type