Cleared Traditional

CD-102 CARBON DIOXIDE ANALYZER/RECOR

K833739 · Instrumentarium Corp. · Anesthesiology
Dec 1983
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K833739 is an FDA 510(k) clearance for the CD-102 CARBON DIOXIDE ANALYZER/RECOR, a Analyzer, Gas, Carbon-monoxide, Gaseous-phase (Class II — Special Controls, product code CCJ), submitted by Instrumentarium Corp. (Tewksbury, US). The FDA issued a Cleared decision on December 16, 1983, 52 days after receiving the submission on October 25, 1983. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1430.

Submission Details

510(k) Number K833739 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 1983
Decision Date December 16, 1983
Days to Decision 52 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CCJ — Analyzer, Gas, Carbon-monoxide, Gaseous-phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1430