K223629
- 510(k) number
- K223629
- Device name
- SpiroSphere, SpiroSphereECG, CardioSphere
- Applicant
- Eresearchtechnology GmbH DE
- Product code
- BTY — Calculator, Predicted Values, Pulmonary Function
- Decision date
- 2024-05-28
- Date received
- 2022-12-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K223629.pdf
Official FDA record: K223629
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.