The following data is part of a premarket notification filed by Contec Medical Systems Co., Ltd with the FDA for Portable Ecg Monitor.
| Device ID | K152863 |
| 510k Number | K152863 |
| Device Name: | Portable ECG Monitor |
| Classification | Electrocardiograph |
| Applicant | CONTEC MEDICAL SYSTEMS CO., LTD NO. 112 QINHUANG WEST STREET, ECONOMIC & TECHNICAL DEVELOPMENT ZONE Qinhuangdao, CN 066004 |
| Contact | Xueyong Li |
| Correspondent | Diana Hong MID-LINK CONSULTING CO., LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-30 |
| Decision Date | 2016-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812324000136 | K152863 | 000 |
| 06945040101505 | K152863 | 000 |
| 04897087200104 | K152863 | 000 |
| 04897087200203 | K152863 | 000 |
| 00810110301535 | K152863 | 000 |
| 04897087206120 | K152863 | 000 |