MODIFICATION TO THE OXYCONALPHA— 510(k) K980094

Name: FDA 510(k) clearance K980094
Creator: U.S. Food and Drug Administration
Published: 1998-07-28

Substantially Equivalent

Erich Jaeger B.V.

FDA 510(k) clearance K980094 for MODIFICATION TO THE OXYCONALPHA, Substantially Equivalent on 1998-07-28. Applicant: Erich Jaeger B.V.. Device class: 2.

Clearance details

Applicant: Erich Jaeger B.V.
Product code: Code BTY
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 1998-01-09
Decision date: 1998-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nl-3981 La Bunnik, NL

Download summary PDF View on FDA.gov ↗

Recent devices under product code BTY

view all

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

More clearances from Erich Jaeger B.V.

view all

K992214 — OXYCON PRO2000-02-22
K984465 — OXYCONALPHA WITH OPTION ECG1999-10-27

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