Current Health Monitoring System Gen 2 (G2)— 510(k) K210133

Name: FDA 510(k) clearance K210133
Creator: U.S. Food and Drug Administration
Published: 2021-09-03

Substantially Equivalent

Current Health

FDA 510(k) clearance K210133 for Current Health Monitoring System Gen 2 (G2), Substantially Equivalent on 2021-09-03. Applicant: Current Health. Device class: 2.

Clearance details

Applicant: Current Health
Product code: Product code MSX
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2021-01-19
Decision date: 2021-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edinburgh, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code MSX

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K261367 — Corsano CardioWatch 287-2 System2026-07-26
K253654 — IntelliVue Measurement Rack 6000 (867317)2026-03-30

Adverse events under product code MSX

product code MSX

Death: 59
Total: 59

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.