510(k) K261580
K261580 is an FDA 510(k) premarket notification submitted by Zbeats, Inc. for the device "ZBPro Diagnostic (Version 2.0)". The FDA issued a decision of Substantially Equivalent on September 11, 2026. The device falls under product code MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm), a Class II device regulated under 21 CFR 870.2800. Zbeats, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 2026
- Date Received
- May 13, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph, Ambulatory, With Analysis Algorithm
- Device Class
- Class II
- Regulation Number
- 870.2800
- Review Panel
- CV
- Submission Type