Paceart, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What Paceart, Inc. makes
Paceart, Inc. manufactures diagnostic and monitoring devices for cardiac patients, including pacemaker function analyzers, remote cardiac event recorders (such as the TX3 and Home Trak Plus systems), and telemetry solutions like CardioVoice and CardioPhone. Their portfolio also includes wrist electrodes for pacemaker testing and specialized patient test systems for remote monitoring of implanted devices.
The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. These products are intended for use in the United States, where regulatory compliance is required for market authorization.
Catalogue
Pacemaker Function Analyzer Ref K870909
Regimes: 510(k) Registry: 510(k)Paceart Cardiovoice Ref K952065
Regimes: 510(k) Registry: 510(k)Paceart TX3 Cardiac Event Recorder Ref K012407
Regimes: 510(k) Registry: 510(k)Paceart Cardiophone Ref K931296
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Paceart Pacemaker Patient Test Syst/Tel Opt Cpts Ref K880283
Regimes: 510(k) Registry: 510(k)Heart Access Plus Cardiac Event Recorder Ref K973141
Regimes: 510(k) Registry: 510(k)Paceart Wrist Electrodes Ref K960721
Regimes: 510(k) Registry: 510(k)Paceart Cpts-86/12 Ref K915632
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Paceart, Inc. have in the registry?
The registry currently lists 9 devices for Paceart, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Paceart, Inc.'s devices?
Among its 9 most recently registered devices, Paceart, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Paceart, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Paceart, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Paceart, Inc. in the registry?
The most recently registered devices listed for Paceart, Inc. include PACEMAKER FUNCTION ANALYZER, PACEART CARDIOVOICE, PACEART TX3 CARDIAC EVENT RECORDER and PACEART CARDIOPHONE.