Cleared Traditional

VITALMAX 4100

K953795 · Pace Tech, Inc. · Anesthesiology
Jul 1996
Decision
322d
Days
Class 2
Risk

About This 510(k) Submission

K953795 is an FDA 510(k) clearance for the VITALMAX 4100, a Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) (Class II — Special Controls, product code CBS), submitted by Pace Tech, Inc. (Clearwater, US). The FDA issued a Cleared decision on July 1, 1996, 322 days after receiving the submission on August 14, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1620.

Submission Details

510(k) Number K953795 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 1995
Decision Date July 01, 1996
Days to Decision 322 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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