510(k) K201887 ยท DQA Oximeter
VS Newborn Heart Rate Monitor
| Applicant | Surepulse Medical Limited, Nottingham, GB |
| Decision | Substantially Equivalent, Jul 23, 2021 |
| Received | Jul 8, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201887
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 12, 2026 | SUREPULSE MEDICAL LTD Surepulse VS Cap Extra Small
REF: SP-159-A1
component of VS Newborn Heart Rate Monitor Open, Classified |
DQA | None listed |
| Feb 12, 2026 | SUREPULSE MEDICAL LTD Surepulse VS Cap Small
REF: SP-160-A1
component of VS Newborn Heart Rate Monitor Open, Classified |
DQA | None listed |
| Feb 12, 2026 | SUREPULSE MEDICAL LTD Surepulse VS Cap Medium
REF: SP-161-A1
component of VS Newborn Heart Rate Monitor Open, Classified |
DQA | None listed |
| Feb 12, 2026 | SUREPULSE MEDICAL LTD Surepulse VS Cap Large
REF: SP-162-A1
component of VS Newborn Heart Rate Monitor Open, Classified |
DQA | None listed |
| Feb 12, 2026 | SUREPULSE MEDICAL LTD Surepulse VS Cap Extra Large
REF: SP-163-A1
component of VS Newborn Heart Rate Monitor Open, Classified |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.