510(k) K932098

CAPNOMAC ULTIMA ANESTHESIA MONITOR by Datex Division Instrumentarium Corp. — Product Code BZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1993
Date Received
May 3, 1993
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