Cleared Traditional

VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR

K863420 · Vitalograph , Ltd. · Anesthesiology
Jan 1987
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K863420 is an FDA 510(k) clearance for the VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR, a Analyzer, Gas, Carbon-monoxide, Gaseous-phase (Class II — Special Controls, product code CCJ), submitted by Vitalograph , Ltd. (Lenexa, US). The FDA issued a Cleared decision on January 15, 1987, 133 days after receiving the submission on September 4, 1986. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1430.

Submission Details

510(k) Number K863420 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 1986
Decision Date January 15, 1987
Days to Decision 133 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