510(k) K904843

OSCAR(TM) II CAPNOMETER & PULSE OXIMETER by Dalton Instrument Corp. — Product Code CBR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1991
Date Received
October 25, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
Device Class
Class II
Regulation Number
868.1700
Review Panel
AN
Submission Type