510(k) clearance
ZBPro Diagnostic (Version 2.0)
- 510(k) number
- K261580
- Applicant
- Zbeats, Inc.
- Decision date
- Sep 11, 2026
- Date received
- May 13, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- MLO
- Device type
- Electrocardiograph, Ambulatory, With Analysis Algorithm
- Device class
- Class II
- Regulation
- 21 CFR 870.2800
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Stony Brook, NY, US