Cleared Traditional

Virtus Metabolic Monitor

K222982 · Virtus Technology Aps · Anesthesiology

Jun 2023

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K222982 is an FDA 510(k) clearance for the Virtus Metabolic Monitor, a Calculator, Predicted Values, Pulmonary Function (Class II — Special Controls, product code BTY), submitted by Virtus Technology Aps (Roennede, DK). The FDA issued a Cleared decision on June 23, 2023, 268 days after receiving the submission on September 28, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number	K222982 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2022
Decision Date	June 23, 2023
Days to Decision	268 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF