Cleared Traditional

RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR

K950101 · Marquette Electronics, Inc. · Anesthesiology
Mar 1995
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K950101 is an FDA 510(k) clearance for the RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR, a Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) (Class II — Special Controls, product code CBS), submitted by Marquette Electronics, Inc. (Milwaukee, US). The FDA issued a Cleared decision on March 21, 1995, 69 days after receiving the submission on January 11, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1620.

Submission Details

510(k) Number K950101 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 1995
Decision Date March 21, 1995
Days to Decision 69 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBS — Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1620

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