510(k) K223629
K223629 is an FDA 510(k) premarket notification submitted by Eresearchtechnology GmbH for the device "SpiroSphere, SpiroSphereECG, CardioSphere". The FDA issued a decision of Substantially Equivalent on May 28, 2024. The device falls under product code BTY (Calculator, Predicted Values, Pulmonary Function), a Class II device regulated under 21 CFR 868.1890. Eresearchtechnology GmbH has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 2024
- Date Received
- December 5, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Calculator, Predicted Values, Pulmonary Function
- Device Class
- Class II
- Regulation Number
- 868.1890
- Review Panel
- AN
- Submission Type