SpiroSphere, SpiroSphereECG, CardioSphere— 510(k) K223629

Name: FDA 510(k) clearance K223629
Creator: U.S. Food and Drug Administration
Published: 2024-05-28

Substantially Equivalent

Eresearchtechnology GmbH

FDA 510(k) clearance K223629 for SpiroSphere, SpiroSphereECG, CardioSphere, Substantially Equivalent on 2024-05-28. Applicant: Eresearchtechnology GmbH. Device class: 2.

Clearance details

Applicant: Eresearchtechnology GmbH
Product code: Code BTY
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 2022-12-05
Decision date: 2024-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Estenfeld, DE

Download summary PDF View on FDA.gov ↗

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