VS Newborn Heart Rate Monitor
FDA 510(k) clearance K201887 · decided 2021-07-23
Clearance details
- K-number
- K201887
- Device name
- VS Newborn Heart Rate Monitor
- Applicant
- Surepulse Medical Limited
- Decision
- Substantially Equivalent
- Date received
- 2020-07-08
- Decision date
- 2021-07-23
- Days to decision
- 380 days
- Clearance type
- Traditional
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Nottingham, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor recall (Z-1356-2026) | SUREPULSE MEDICAL LTD | 2026-02-12 |
| Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor recall (Z-1357-2026) | SUREPULSE MEDICAL LTD | 2026-02-12 |
| Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor recall (Z-1358-2026) | SUREPULSE MEDICAL LTD | 2026-02-12 |
| Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor recall (Z-1359-2026) | SUREPULSE MEDICAL LTD | 2026-02-12 |
| Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor recall (Z-1360-2026) | SUREPULSE MEDICAL LTD | 2026-02-12 |