Cleared Traditional

POET IQ WITH FIVE AGENT CAPABILITY

K942737 · Criticare Systems, Inc. · Anesthesiology
Feb 1995
Decision
244d
Days
Class 2
Risk

About This 510(k) Submission

K942737 is an FDA 510(k) clearance for the POET IQ WITH FIVE AGENT CAPABILITY, a Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) (Class II — Special Controls, product code CBS), submitted by Criticare Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on February 9, 1995, 244 days after receiving the submission on June 10, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1620.

Submission Details

510(k) Number K942737 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 1994
Decision Date February 09, 1995
Days to Decision 244 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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