K233864
- 510(k) number
- K233864
- Device name
- ASSURE Wearable ECG
- Applicant
- Kestra Medical Technologies, Inc. WA · US
- Product code
- MWJ — Electrocardiograph, Ambulatory (Without Analysis)
- Decision date
- 2024-05-07
- Date received
- 2023-12-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K233864.pdf
Official FDA record: K233864
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.