OSCAR(TM) II CAPNOMETER & PULSE OXIMETER— 510(k) K904843

Name: FDA 510(k) clearance K904843
Creator: U.S. Food and Drug Administration
Published: 1991-04-09

Substantially Equivalent

Dalton Instrument Corp.

FDA 510(k) clearance K904843 for OSCAR(TM) II CAPNOMETER & PULSE OXIMETER, Substantially Equivalent on 1991-04-09. Applicant: Dalton Instrument Corp.. Device class: 2.

Clearance details

Applicant: Dalton Instrument Corp.
Product code: Code CBR
Device class: Class 2
Regulation: 21 CFR 868.1700
Advisory panel: Anesthesiology
Date received: 1990-10-25
Decision date: 1991-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, Finland, FI

Download summary PDF View on FDA.gov ↗

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