Cleared Traditional

MGA 2000 GAS ANALYSER

K854076 · Airspec , Ltd. · Toxicology
Dec 1985
Decision
65d
Days
Class 1
Risk

About This 510(k) Submission

K854076 is an FDA 510(k) clearance for the MGA 2000 GAS ANALYSER, a Mass Spectrometer, Clinical Use (Class I — General Controls, product code DOP), submitted by Airspec , Ltd. (Tn 16 3bw, England, GB). The FDA issued a Cleared decision on December 11, 1985, 65 days after receiving the submission on October 7, 1985. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2860.

Submission Details

510(k) Number K854076 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 1985
Decision Date December 11, 1985
Days to Decision 65 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DOP — Mass Spectrometer, Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2860