Cleared Traditional

Tec 820, Tec 850

K172702 · Datex-Ohmeda, Inc. · Anesthesiology
Jan 2018
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K172702 is an FDA 510(k) clearance for the Tec 820, Tec 850, a Vaporizer, Anesthesia, Non-heated (Class II — Special Controls, product code CAD), submitted by Datex-Ohmeda, Inc. (Madison, US). The FDA issued a Cleared decision on January 4, 2018, 119 days after receiving the submission on September 7, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5880.

Submission Details

510(k) Number K172702 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 2017
Decision Date January 04, 2018
Days to Decision 119 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAD — Vaporizer, Anesthesia, Non-heated
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5880

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