Cleared Traditional

VITALOGRAPH-BREATHCO MONITOR

K892524 · Vitalograph , Ltd. · Anesthesiology
May 1989
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K892524 is an FDA 510(k) clearance for the VITALOGRAPH-BREATHCO 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 May 5, 1989, 24 days after receiving the submission on April 11, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1430.

Submission Details

510(k) Number K892524 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1989
Decision Date May 05, 1989
Days to Decision 24 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