510(k) K212317 ยท MWJ Electrocardiograph, Ambulatory (Without Analysis)
Eclipse MINI Model 98900
| Applicant | Spacelabs Healthcare, Ltd., Hertford, GB |
| Decision | Substantially Equivalent, Nov 7, 2022 |
| Received | Jul 26, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212317
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2024 | Spacelabs Healthcare, Ltd. Eclipse Mini REF 98900
The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient s electrocardiogram. Open, Classified |
MWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.