Bio-Signal Group Corporation
Country not established
- Devices
- 1
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Bio-Signal Group Corporation makes
Bio-Signal Group Corporation manufactures microelectrode EEG (microEEG) systems designed for high-resolution neural signal recording, enabling detailed monitoring of brain activity at the microcircuit level.
These systems are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
Microeeg System Ref K112817
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Bio-Signal Group Corporation, initiated on 2019-10-29. By recorded status: 2 terminated. The reasons filed fall into these groups: sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 2
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 29 Oct 2019 Z-0704-2020 Class II Terminated Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)
- 29 Oct 2019 Z-0705-2020 Class II Terminated Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)
Frequently asked questions
How many devices does Bio-Signal Group Corporation have in the registry?
The registry currently lists 1 device for Bio-Signal Group Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bio-Signal Group Corporation's devices?
Among its 1 most recently registered device, Bio-Signal Group Corporation has devices listed in FDA 510(k) (1 device).
What risk classes do Bio-Signal Group Corporation's devices fall under?
Among its 1 most recently registered device, the classes recorded for Bio-Signal Group Corporation's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Bio-Signal Group Corporation?
FDA recall records list 2 recalls initiated by Bio-Signal Group Corporation, the most recent initiated on 29 Oct 2019. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Bio-Signal Group Corporation in the registry?
The most recently registered devices listed for Bio-Signal Group Corporation include MICROEEG SYSTEM.