Cleared Traditional

GAS MODULE II, MODEL 0998-00-0143

K974903 · Datascope Corp. · Anesthesiology
Mar 1998
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K974903 is an FDA 510(k) clearance for the GAS MODULE II, MODEL 0998-00-0143, a Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) (Class II — Special Controls, product code CBS), submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on March 13, 1998, 72 days after receiving the submission on December 31, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1620.

Submission Details

510(k) Number K974903 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 1997
Decision Date March 13, 1998
Days to Decision 72 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

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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