The following data is part of a premarket notification filed by Epi Mobile Health Solutions (s) Pte Ltd with the FDA for Epi Mini Ecg Portable Health Monitoring System (epi Mini).
| Device ID | K121628 |
| 510k Number | K121628 |
| Device Name: | EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI) |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | EPI MOBILE HEALTH SOLUTIONS (S) PTE LTD 1200 19TH STREET, NW Washington, DC 20032 |
| Contact | Karl M Nobert |
| Correspondent | Karl M Nobert EPI MOBILE HEALTH SOLUTIONS (S) PTE LTD 1200 19TH STREET, NW Washington, DC 20032 |
| Product Code | DXH |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DSH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-04 |
| Decision Date | 2013-06-25 |
| Summary: | summary |