The following data is part of a premarket notification filed by Beijing Choice Electronic Technololgy Co., Ltd. with the FDA for Handheld Ecg Monitor.
| Device ID | K112622 |
| 510k Number | K112622 |
| Device Name: | HANDHELD ECG MONITOR |
| Classification | Electrocardiograph |
| Applicant | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-08 |
| Decision Date | 2012-07-19 |
| Summary: | summary |