ASCOM US, INC.

FDA Device Registration & Listing · Morrisville, NC, US · Registration 3008855170

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008855170
FEI Number
3008855170
Entity Name
ASCOM US, INC.
City/State/Country
Morrisville, NC, US
Establishment Address
300 Perimeter Park Dr Ste D, Morrisville, NC 27560, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
ASCOM SWEDEN AB (Owner Number: 10037837)
Owner / Operator Contact Address
300 Perimeter Park Drive, Morrisville, NC 27560, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K180430
PMA Number
N/A

All Registered Proprietary Names

Telligence Unite Connect For Nurse Call Unite View Unite Connect for Clinical Systems Digistat Smart Central

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IQA System, Environmental Control, Powered Physical Medicine Class 2 890.3725 2012-12-19
MSX System, Network And Communication, Physiological Monitors Cardiovascular Class 2 870.2300 2019-04-18
MSX System, Network And Communication, Physiological Monitors Cardiovascular Class 2 870.2300 2025-12-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ASCOM SWEDEN AB
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3008952681 ASCOM SWEDEN AB Goteborg Vastra Gotaland, SE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K973527 Data Critical Corp. CARDIO-PAGER SYSTEM 1998-03-31
K182637 Philips Medizin Systeme Boeblingen GmbH Philips IntelliVue XDS Software 2019-04-26

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3008952681 ASCOM SWEDEN AB Goteborg Vastra Gotaland, SE
3014024339 AIPHONE CORPORATION Redmond, WA, US
3002713667 CREST ELECTRONICS INC. DASSEL, MN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008855170. Last updated year: 2026. Please use registration number 3008855170 when referencing this establishment in official correspondence.
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