Galix Biomedical Instrumentation, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Galix Biomedical Instrumentation, Inc. makes
Galix Biomedical Instrumentation, Inc. manufactures digital ambulatory ECG recorders, including multi-channel models for continuous cardiac monitoring, as well as ECG professional analysis stations and pacemaker monitoring systems. Their devices are designed for long-term patient monitoring and clinical diagnostics, supporting both portable and stationary use in healthcare settings.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised via the 510(k) clearance pathway. These devices are listed in the FDA’s 510(k) database, adhering to U.S. regulatory standards for cardiac monitoring equipment. The company is headquartered in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Galix Pacestar Ref K023080
Regimes: 510(k) Registry: 510(k)Galix Gbi -3S-LP Ref K992706
Regimes: 510(k) Registry: 510(k)Galix Winter Ref K030145
Regimes: 510(k) Registry: 510(k)3 Channel Digital Ambulatory Ecg Recorder Ref K971670
Regimes: 510(k) Registry: 510(k)Galix Ecg Professional Station Ref K051163
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Galix Biomedical Instrumentation, Inc. have in the registry?
The registry currently lists 6 devices for Galix Biomedical Instrumentation, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Galix Biomedical Instrumentation, Inc.'s devices?
Among its 6 most recently registered devices, Galix Biomedical Instrumentation, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Galix Biomedical Instrumentation, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Galix Biomedical Instrumentation, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Galix Biomedical Instrumentation, Inc. in the registry?
The most recently registered devices listed for Galix Biomedical Instrumentation, Inc. include 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM, GALIX PACESTAR, GALIX GBI -3S-LP and GALIX WINTER.