Bay Labs, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Bay Labs, Inc. makes
Bay Labs, Inc. develops software tools for cardiac imaging analysis, including automated solutions for calculating ejection fraction from echocardiogram data and systems to assist in interpreting ultrasound images for diagnostic purposes.
These products are classified as Class II medical devices under FDA regulations and are authorised through the 510(k) clearance process. The company is based in the United States.
Catalogue
Caption Guidance Ref DEN190040
Regimes: De Novo Registry: De NovoEchoMD Automated Ejection Fraction Software Ref K173780
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bay Labs, Inc. have in the registry?
The registry currently lists 2 devices for Bay Labs, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bay Labs, Inc.'s devices?
Among its 2 most recently registered devices, Bay Labs, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Bay Labs, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Bay Labs, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bay Labs, Inc. in the registry?
The most recently registered devices listed for Bay Labs, Inc. include Caption Guidance and EchoMD Automated Ejection Fraction Software.