510(k) K173780
K173780 is an FDA 510(k) premarket notification submitted by Bay Labs, Inc. for the device "EchoMD Automated Ejection Fraction Software". The FDA issued a decision of Substantially Equivalent on June 14, 2018. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Bay Labs, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 2018
- Date Received
- December 12, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type