Medical Device Manufacturer · US , San Francisco , CA

Bay Labs, Inc. - FDA 510(k) Cleared Devices

2 submissions · 1 cleared · Since 2018
2
Total
1
Cleared
1
Denied
FDA 510(k) Regulatory Record - Bay Labs, Inc. Radiology ✕
2 devices
1-2 of 2
Not Cleared Feb 07, 2020
Caption Guidance
DEN190040 · QJU
Radiology · 164d
Cleared Jun 14, 2018
EchoMD Automated Ejection Fraction Software
K173780 · LLZ
Radiology · 184d
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