The following data is part of a premarket notification filed by Bay Labs, Inc. with the FDA for Echomd Automated Ejection Fraction Software.
| Device ID | K173780 |
| 510k Number | K173780 |
| Device Name: | EchoMD Automated Ejection Fraction Software |
| Classification | System, Image Processing, Radiological |
| Applicant | Bay Labs, Inc. 290 King Street San Francisco, CA 94107 |
| Contact | Charles Cadieu |
| Correspondent | Yarmela Pavlovic Hogan Lovells US LLP 3 Embarcadero Center Suite 1500 San Francisco, CA 94111 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-12 |
| Decision Date | 2018-06-14 |
| Summary: | summary |