Digistat Care— 510(k) K261287
Substantially EquivalentAscom Ums Srl Unipersonale
FDA 510(k) clearance K261287 for Digistat Care, Substantially Equivalent on 2026-09-12. Applicant: Ascom Ums Srl Unipersonale. Device class: 2.
Summary
Digistat Care falls under product code MSX: network and communication systems for physiological monitors. The record doesn't describe what it connects to.
Class II, 21 CFR 870.2300. The Cardiovascular panel reviewed it as a Traditional 510(k).
Ascom UMS filed from Scandicci, Italy. The review took 145 days (April 20 to September 12, 2026).
Clearance details
- Applicant
- Ascom Ums Srl Unipersonale
- Product code
- Product code MSX
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scandicci (Fi), IT
Recent devices under product code MSX
view allMore clearances from Ascom Ums Srl Unipersonale
view allAdverse events under product code MSX
product code MSX- Death
- 59
- Total
- 59
Source: openFDA MAUDE database, through . 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.