510(k) K212957 ยท DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
BioButton System
| Applicant | Biolntellisense, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Dec 12, 2022 |
| Received | Sep 16, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212957
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2024 | Biointellisense Inc. BioButton REF BIOST06040 with Software version 3.0.20
The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare setti Open, Classified |
DRG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.