Data / Medical devices / United States / Ascom Us, Inc.
Ascom Us, Inc.: FDA-registered device maker in Morrisville, NC, United States, 2 510(k) clearances
Ascom Us, Inc. is registered with the FDA (registration 3008855170) in Morrisville, NC, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 23, 2018. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008855170
- Address
- 300 Perimeter Park Dr Ste D, Morrisville, NC, United States, 27560
- Owner or operator
- ASCOM SWEDEN AB (10037837)
- Roles
- Complaint file establishment
- First device listed
- December 19, 2012
- Registered through
- 2026
- Brand names listed
- Digistat Smart Central, Telligence, Unite Connect For Nurse Call, Unite Connect for Clinical Systems, Unite View
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Environmental Control, Powered | IQA | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Network And Communication, Physiological Monitors | MSX | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 23, 2018 | K180430 | Digistat Smart Central | MSX | Substantially Equivalent | Ascom Ums Srl Unipersonale | accessdata.fda.gov |
| April 3, 2018 | K180566 | Unite Connect for Clinical Systems | MSX | Substantially Equivalent | Ascom Sweden AB | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 10, 2015 | 73578 | Class II | Terminated | Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0). | Due to a malfunction of software, the secondary module will not automatically take over messaging if the primary module fails after a software upgrade to one of the other affected versions. Messages from GE Carescape/Nurse Call will not forward to handset until primary module is restored. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Environmental Control, Powered
- All makers of System, Network And Communication, Physiological Monitors
Updated November 23, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.