Unite Connect for Clinical Systems— 510(k) K180566
Substantially EquivalentAscom Sweden AB
FDA 510(k) clearance K180566 for Unite Connect for Clinical Systems, Substantially Equivalent on 2018-04-03. Applicant: Ascom Sweden AB. Device class: 2.
Clearance details
- Applicant
- Ascom Sweden AB
- Product code
- Code MSX
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Goteborg, SE
Recent devices under product code MSX
view allMore clearances from Ascom Sweden AB
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.