Virtus Metabolic Monitor— 510(k) K222982

Substantially Equivalent

Virtus Technology Aps

FDA 510(k) clearance K222982 for Virtus Metabolic Monitor, Substantially Equivalent on 2023-06-23. Applicant: Virtus Technology Aps. Device class: 2.

Clearance details

Applicant: Virtus Technology Aps
Product code: Code BTY
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 2022-09-28
Decision date: 2023-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roennede, DK

Download summary PDF View on FDA.gov ↗

Recent devices under product code BTY

K260242 — CPETWise Platform2026-08-20
K242809 — Ascent Cardiorespiratory Diagnostic Software2024-10-17
K223629 — SpiroSphere, SpiroSphereECG, CardioSphere2024-05-28
K231561 — Pulmonary Function Tester, Model: A92024-02-21
K221030 — Model 9100 PFT/DICO2022-07-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.