Bio-Logic Systems Corp.
United StatesFDA applicant, unverified
- Devices
- 46
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Bio-Logic Systems Corp. makes
Bio-Logic Systems Corp. manufactures disposable cutaneous electrodes for medical diagnostics, as well as evoked response systems for neurological assessments. Their product line includes ambulatory EEG recorders, such as the CEEGRAPH Traveler, and sleep monitoring tools like the SleepScan airflow pressure transducer and SleepScan products with built-in oximetry. The company also produces otoacoustic emission measurement systems, including the Scout Sport and EMAV emission averaging tests, alongside insert earphones and automated event analysis software for diagnostic use. Additional offerings include modifications for evoked potential systems and data storage solutions like the Bio-Logic Banker.
The company’s devices fall under Class II regulatory classification in the U.S. and are listed in the FDA 510(k) registry as part of their premarket submission records. Their products are designed for neurological, auditory, and sleep diagnostics, adhering to U.S. medical device regulations. The manufacturer is based in the United States.
Catalogue
Search and filter all 46 devicesFDA recalls
FDA recall records list 2 recalls initiated by Bio-Logic Systems Corp., the earliest on 2007-02-26 and the most recent on 2007-07-26. By recorded status: 2 terminated. The reasons filed fall into these groups: electrical or power and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2007
- 26 Jul 2007 Z-0001-2008 Unclassified (pre-2012) Terminated Bio-logic System Corp Camera Pole may weaken and detach at the base of the telescoping camera pole during transport causing pole to break at the welded base and fall.
- 26 Feb 2007 Z-0761-2007 Unclassified (pre-2012) Terminated Battery and Battery Compartment; incorrect placement in the Netlink Traveler unit which caused a short in the wiring of the battery pack and overheating.
Frequently asked questions
How many devices does Bio-Logic Systems Corp. have in the registry?
The registry currently lists 46 devices for Bio-Logic Systems Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bio-Logic Systems Corp.'s devices?
Among its 46 most recently registered devices, Bio-Logic Systems Corp. has devices listed in FDA 510(k) (46 devices).
What risk classes do Bio-Logic Systems Corp.'s devices fall under?
Among its 46 most recently registered devices, the classes recorded for Bio-Logic Systems Corp.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Bio-Logic Systems Corp.?
FDA recall records list 2 recalls initiated by Bio-Logic Systems Corp., the most recent initiated on 26 Jul 2007. 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-Logic Systems Corp. in the registry?
The most recently registered devices listed for Bio-Logic Systems Corp. include SLEEPSCAN, DISPOSABLE CUTANEOUS ELECTRODES, BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM and CEEGRAPH TRAVELER AMBULATORY EEG RECORDER.