Digistat Smart Central— 510(k) K180430

Name: FDA 510(k) clearance K180430
Creator: U.S. Food and Drug Administration
Published: 2018-11-23

Substantially Equivalent

Ascom Ums Srl Unipersonale

FDA 510(k) clearance K180430 for Digistat Smart Central, Substantially Equivalent on 2018-11-23. Applicant: Ascom Ums Srl Unipersonale. Device class: 2.

Clearance details

Applicant: Ascom Ums Srl Unipersonale
Product code: Code MSX
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2018-02-16
Decision date: 2018-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scandicci (Fi), IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code MSX

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K253654 — IntelliVue Measurement Rack 6000 (867317)2026-03-30
K243270 — TigerConnect Alarm Management2025-09-30

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.