K243236
- 510(k) number
- K243236
- Device name
- WHOOP ECG (electrocardiogram) Feature (1.0)
- Applicant
- Whoop., Inc. MA · US
- Product code
- QDA — Electrocardiograph Software For Over-The-Counter Use
- Decision date
- 2025-04-04
- Date received
- 2024-10-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K243236.pdf
Official FDA record: K243236
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.