K241101
- 510(k) number
- K241101
- Device name
- BioButton System
- Applicant
- Biointellisense, Inc. CA · US
- Product code
- DRG — Transmitters And Receivers, Physiological Signal, Ra
- Decision date
- 2024-09-26
- Date received
- 2024-04-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K241101.pdf
Official FDA record: K241101
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.