Cleared Traditional

K223818 - Model 9160 VitaloQUB
(FDA 510(k) Clearance)

K223818 · Vitalograph (Ireland) , Ltd. · Anesthesiology

May 2023

Decision

155d

Days

Class 2

Risk

K223818 is an FDA 510(k) clearance for the Model 9160 VitaloQUB. This device is classified as a Plethysmograph, Volume (Class II — Special Controls, product code JEH).

Submitted by Vitalograph (Ireland) , Ltd. (Ennis Co Clare, IE). The FDA issued a Cleared decision on May 25, 2023, 155 days after receiving the submission on December 21, 2022.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1760.

Submission Details

510(k) Number	K223818 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 2022
Decision Date	May 25, 2023
Days to Decision	155 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF