Cleared Traditional

Carestation 750/750c

K213867 · Datex-Ohmeda, Inc. · Anesthesiology
Mar 2023
Decision
473d
Days
Class 2
Risk

About This 510(k) Submission

K213867 is an FDA 510(k) clearance for the Carestation 750/750c, a Gas-machine, Anesthesia (Class II — Special Controls, product code BSZ), submitted by Datex-Ohmeda, Inc. (Madison, US). The FDA issued a Cleared decision on March 28, 2023, 473 days after receiving the submission on December 10, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K213867 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2021
Decision Date March 28, 2023
Days to Decision 473 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSZ — Gas-machine, Anesthesia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5160

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