510(k) K243252
- Device
- ZBPro Diagnostic
- Applicant
- Zbeats, Inc.
- 510(k) number
- K243252
- Product code
- DPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-07-10
- Date received
- 2024-10-15
- Regulation
- 870.2340
- Classification name
- Electrocardiograph
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Bin Fang
- Address
- 25 Health Sciences Dr. Stony Brook NY US 11790 11790
FDA Registration Numbers
- 9710602
- 3005488716
- 3004906872
- 3007734888
- 3042928308
- 3014541700
- 3008716327
- 3013501110
- 3019388613
- 3010157426
- 3009443693
- 2084041
- 3011861727
- 3003832357
- 3033536319
- 3001373226
- 3015134086
- 3009499478
- 1066270
- 3008505660
- 3033558564
- 3018094310
- 8030673
- 3010698831
- 3012302888
- 3003294644
- 3030154814
- 3018783526
- 9611295
- 3010089768
- 3030639099
- 3043479346
- 3003681187
- 3011651230
- 1523530
- 2182208
- 3010097171
- 3003591740
- 3013596024
- 3013500228
- 3012027770
- 3013188547
- 3013679558
- 9610816
- 1220477
- 3014848734
- 3014522540
- 9680510
- 3031786139
- 3011235999
- 3007029079
- 3031570367
- 3010419931
- 3007836437
- 3005877899
- 3008483389
- 3012250536
- 3013689228
- 3016852448
- 1126271
- 3009183442
- 3011359729
- 3009607734
- 8030245
- 3000130829
- 3004582233
- 8030978
- 3005521864
- 3008164770
- 3003263092
- 3007770164
- 3008293988
- 1450057
- 3008921101
- 3016931915
- 3012404027
- 3007413079
- 1220908
- 3010082909
Source Documents
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| K231160 | Cardio Q50, Cardio Q70 | Bionet Co., Ltd. | 2023-12-15 |