Clearance Summary
SpiroSphere, SpiroSphereECG, CardioSphere received FDA 510(k) clearance under submission number K223629, sponsored by Eresearchtechnology GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2024-05-28.
- Submission: K223629
- Applicant / Sponsor: Eresearchtechnology GmbH
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1890
- Decision date: 2024-05-28
Classification & Regulation
This clearance is catalogued under FDA product code BTY and 21 CFR 868.1890, within the Anesthesiology review panel as a Class II device.