Device Atlas

Oscar(Tm) II Capnometer & Pulse Oximeter

Q: What is the product code of K904843?

The FDA product code is CBR – Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.), a Class II (moderate risk) device regulated under 21 CFR 868.1700.

FDA 510(k) K904843 · Dalton Instrument Corp.

Substantially Equivalent

510(k) numberK904843

Submission

Device name: Oscar(Tm) II Capnometer & Pulse Oximeter
Applicant: Dalton Instrument Corp.
Helsinki, Finland, FI
Received: October 25, 1990
Decision date: April 9, 1991
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: CBR – Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
Device class: Class II (moderate risk)
Regulation: 21 CFR 868.1700
Specialty: Anesthesiology

Other 510(k)s with product code CBR

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K112173	Speacelabs Multigas ModuleCBR · Special	Spacelabs Healthcare	10/05/2011SE
K053599	Spacelabs Medical Multigas Analyzer Module 91518 and AccessoriesCBR · Special	Spacelabs Medical, Inc.	04/19/2006SE
K954962	Spacelabs Medical Multigas AnalyzerCBR · Traditional	Spacelabs, Inc.	05/31/1996SE
K853360	N20 TestCBR · Traditional	Erich Jaeger, Inc.	09/03/1985SE

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K101719	Tacamo Manual WheelchairIOR · Abbreviated	08/25/2010SE
K850178	Dalton Folding WheelchairsIOR · Traditional	04/25/1985SE

Questions and answers

When was Oscar(Tm) II Capnometer & Pulse Oximeter cleared by the FDA?

Oscar(Tm) II Capnometer & Pulse Oximeter (K904843) received a 510(k) decision of Substantially Equivalent on April 9, 1991, 166 days after the submission was received.

What is the product code of K904843?

The FDA product code is CBR – Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.), a Class II (moderate risk) device regulated under 21 CFR 868.1700.