Cleared Traditional

OSCAR(TM) II CAPNOMETER & PULSE OXIMETER

K904843 · Dalton Instrument Corp. · Anesthesiology
Apr 1991
Decision
166d
Days
Class 2
Risk

About This 510(k) Submission

K904843 is an FDA 510(k) clearance for the OSCAR(TM) II CAPNOMETER & PULSE OXIMETER, a Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.) (Class II — Special Controls, product code CBR), submitted by Dalton Instrument Corp. (Helsinki, Finland, FI). The FDA issued a Cleared decision on April 9, 1991, 166 days after receiving the submission on October 25, 1990. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1700.

Submission Details

510(k) Number K904843 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 1990
Decision Date April 09, 1991
Days to Decision 166 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CBR — Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1700