Cleared Traditional

TONOCAP, TC-200 AND ACCESSORY CATHETERS

K962638 · Instrumentarium Corp. · Anesthesiology
Apr 1997
Decision
273d
Days
Class 2
Risk

About This 510(k) Submission

K962638 is an FDA 510(k) clearance for the TONOCAP, TC-200 AND ACCESSORY CATHETERS, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Instrumentarium Corp. (Tewksbury, US). The FDA issued a Cleared decision on April 4, 1997, 273 days after receiving the submission on July 5, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K962638 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 1996
Decision Date April 04, 1997
Days to Decision 273 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code CCK — Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1400

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