510(k) K243236 ยท QDA Electrocardiograph Software For Over-The-Counter Use
WHOOP ECG (electrocardiogram) Feature (1.0)
| Applicant | Whoop., Inc., Boston MA, US |
| Decision | Substantially Equivalent, Apr 4, 2025 |
| Received | Oct 10, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243236
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.