510(k) K802614

ENGSTROM EMMA ANESTHETIC GAS MONITOR by Lkb Instruments, Inc. — Product Code CBS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1981
Date Received
October 21, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
Device Class
Class II
Regulation Number
868.1620
Review Panel
AN
Submission Type