Digistat Smart Central— 510(k) K180430
Substantially EquivalentAscom Ums Srl Unipersonale
FDA 510(k) clearance K180430 for Digistat Smart Central, Substantially Equivalent on 2018-11-23. Applicant: Ascom Ums Srl Unipersonale.
Clearance details
- Applicant
- Ascom Ums Srl Unipersonale
- Product code
- Code MSX
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scandicci (Fi), IT
Adverse 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.