K250233
- 510(k) number
- K250233
- Device name
- PreemptiveAI Clinical SDK
- Applicant
- Measure Labs, Inc. (Dba Preemptiveai, Inc.) WA · US
- Product code
- DXH — Transmitters And Receivers, Electrocardiograph, Tele
- Decision date
- 2026-02-13
- Date received
- 2025-01-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250233.pdf
Official FDA record: K250233
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.