Cleared Traditional

SpiroSphere, SpiroSphereECG, CardioSphere

K223629 · Eresearchtechnology GmbH · Cardiovascular

May 2024

Decision

540d

Days

Class 2

Risk

About This 510(k) Submission

K223629 is an FDA 510(k) clearance for the SpiroSphere, SpiroSphereECG, CardioSphere, a Calculator, Predicted Values, Pulmonary Function (Class II — Special Controls, product code BTY), submitted by Eresearchtechnology GmbH (Estenfeld, DE). The FDA issued a Cleared decision on May 28, 2024, 540 days after receiving the submission on December 5, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number	K223629 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 05, 2022
Decision Date	May 28, 2024
Days to Decision	540 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF