VS Newborn Heart Rate Monitor— 510(k) K201887

Substantially Equivalent

Surepulse Medical Limited

FDA 510(k) clearance K201887 for VS Newborn Heart Rate Monitor, Substantially Equivalent on 2021-07-23. Applicant: Surepulse Medical Limited.

Clearance details

Applicant: Surepulse Medical Limited
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2020-07-08
Decision date: 2021-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nottingham, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.