OXYCON-ALPHA— 510(k) K942230

Substantially Equivalent

Mijnhardt B.V.

FDA 510(k) clearance K942230 for OXYCON-ALPHA, Substantially Equivalent on 1995-03-20. Applicant: Mijnhardt B.V.. Device class: 2.

Clearance details

Applicant: Mijnhardt B.V.
Product code: Code BTY
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 1994-05-06
Decision date: 1995-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 3981 Ae Bunnik, NL

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
K222982 — Virtus Metabolic Monitor2023-06-23

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