Cleared Traditional

CARESCAPE R860

K210384 · Datex-Ohmeda, Inc. · Anesthesiology
Nov 2021
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K210384 is an FDA 510(k) clearance for the CARESCAPE R860, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Datex-Ohmeda, Inc. (Madison, US). The FDA issued a Cleared decision on November 4, 2021, 268 days after receiving the submission on February 9, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K210384 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 2021
Decision Date November 04, 2021
Days to Decision 268 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBK — Ventilator, Continuous, Facility Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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