Cleared Traditional

A9800 ANESTHESIA WORKSTATION

K131790 · Oricare, Inc. · Anesthesiology
May 2014
Decision
325d
Days
Class 2
Risk

About This 510(k) Submission

K131790 is an FDA 510(k) clearance for the A9800 ANESTHESIA WORKSTATION, a Gas-machine, Anesthesia (Class II — Special Controls, product code BSZ), submitted by Oricare, Inc. (Quakertow., US). The FDA issued a Cleared decision on May 9, 2014, 325 days after receiving the submission on June 18, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K131790 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 2013
Decision Date May 09, 2014
Days to Decision 325 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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