The following data is part of a premarket notification filed by Sonoscape Company Limited with the FDA for Digital Electrocardiographs.
| Device ID | K131262 |
| 510k Number | K131262 |
| Device Name: | DIGITAL ELECTROCARDIOGRAPHS |
| Classification | Electrocardiograph |
| Applicant | SONOSCAPE COMPANY LIMITED P.O. BOX 120-119 Shanghai, CN 237-023 |
| Contact | Diana Hong |
| Correspondent | Diana Hong SONOSCAPE COMPANY LIMITED P.O. BOX 120-119 Shanghai, CN 237-023 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-03 |
| Decision Date | 2013-11-14 |
| Summary: | summary |