Panels › Gastroenterology, Urology › Product code EXY · Class 2
Uroflowmeter
Regulation 876.1800
0510(k)s in 12 months (16 all time)
1recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in EXY
| Company | 510(k)s | Recalls |
|---|---|---|
| Life-Tech Intl., Inc. | 3 | 0 |
| Albyn Medical , Ltd. | 1 | 0 |
| Be Technologies, Inc. | 1 | 0 |
| Biodan Medical Systems, Ltd. | 1 | 0 |
| Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) | 0 | 1 |
| Dantec Medical, Inc. | 1 | 0 |
| Diagnostic Ultrasound Corp. | 1 | 0 |
| Emano Metrics, Inc. | 0 | 1 |
| Eutectic Electronics, Inc. | 1 | 0 |
| Fiberoptic Sensor Technlogies, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 22, 2026 | Emano Metrics, Inc. Emano Flow with software version v2.0.0
GS1 GTIN code: 199874903484
Emano Flow is a smartphone-based acoustic uroflowmetry system. Software-only device that measures urinary flow rate and voided volu Open, Classified |
EXY | None listed |
| Apr 21, 2022 | Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) ProudP Everyday Uroflow Tracker
Software Version 1.x.x
Software Version 1.2.0 or earlier Terminated |
EXY | None listed |
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