Accucore, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What Accucore, Inc. makes
Accucore, Inc. manufactures cardiac telemetry monitors, including models designed for arrhythmia detection and remote patient monitoring. These devices support real-time cardiac data transmission, such as the PCI Model 2041 series and the Datascope Model VISA Central Monitor. Additional offerings include standalone telemetry units like the Model SCR-1000 and the Pacific Communications Model 1100, which facilitate wireless patient monitoring in clinical settings.
The company’s portfolio consists of Class II medical devices, all of which are listed under the FDA’s 510(k) clearance process. These devices are intended for use in the United States, where regulatory compliance is maintained through the FDA’s premarket notification requirements. No other regulatory registries or jurisdictions are specified.
Catalogue
Pci Model 2041-Pc Telemetry Monitor W/Arrhythmia Ref K901032
Regimes: 510(k) Registry: 510(k)Model Scr-1000 Ref K913400
Regimes: 510(k) Registry: 510(k)Pci Model 2041-Pc Telemetry Monitor Ref K901031
Regimes: 510(k) Registry: 510(k)Pci Model 2041-A Telemetry Monitor Ref K894340
Regimes: 510(k) Registry: 510(k)Pci Model 2041-B Telemetry Monitor Ref K896775
Regimes: 510(k) Registry: 510(k)Datascope Model Visa Central Monitor Ref K913576
Regimes: 510(k) Registry: 510(k)Pci Model RS100 Telemetry Monitor Ref K874387
Regimes: 510(k) Registry: 510(k)Model 2041-Pc/St Cardiac Telemetry Monitor Ref K925411
Regimes: 510(k) Registry: 510(k)Pacific Communications Model 1100 Ref K942147
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Accucore, Inc. have in the registry?
The registry currently lists 9 devices for Accucore, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Accucore, Inc.'s devices?
Among its 9 most recently registered devices, Accucore, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Accucore, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Accucore, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Accucore, Inc. in the registry?
The most recently registered devices listed for Accucore, Inc. include PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA, MODEL SCR-1000, PCI MODEL 2041-PC TELEMETRY MONITOR and PCI MODEL 2041-A TELEMETRY MONITOR.