K242967
- 510(k) number
- K242967
- Device name
- Loss of Pulse Detection
- Applicant
- Fitbit CA · US
- Product code
- SDY — Loss Of Pulse Notification Software
- Decision date
- 2025-02-25
- Date received
- 2024-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K242967.pdf
Official FDA record: K242967
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.