510(k) K211651 ยท MWJ Electrocardiograph, Ambulatory (Without Analysis)
Eclipse PRO
| Applicant | Spacelabs Healthcare, Ltd., Hertford, GB |
| Decision | Substantially Equivalent, Nov 22, 2021 |
| Received | May 28, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211651
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2024 | Spacelabs Healthcare, Ltd. Eclipse PRO REF 98700
The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory 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.