510(k) K832565

OHIO 5400 VOLUME MONITOR by Airco/Ohio Medical Products — Product Code BZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1983
Date Received
August 2, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Monitoring (W/Wo Alarm)
Device Class
Class II
Regulation Number
868.1850
Review Panel
AN
Submission Type