The following data is part of a premarket notification filed by Contec Medical System Co., Ltd. with the FDA for Dynamic Ecg System Model Tlc5000.
| Device ID | K101273 |
| 510k Number | K101273 |
| Device Name: | DYNAMIC ECG SYSTEM MODEL TLC5000 |
| Classification | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Applicant | CONTEC MEDICAL SYSTEM CO., LTD. SUITE 5D, NO. 19, LANE 999 ZHONGSHAN NO. 2 ROAD(S) Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong CONTEC MEDICAL SYSTEM CO., LTD. SUITE 5D, NO. 19, LANE 999 ZHONGSHAN NO. 2 ROAD(S) Shanghai, CN 200030 |
| Product Code | MLO |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-06 |
| Decision Date | 2011-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945040101499 | K101273 | 000 |
| 06945040101406 | K101273 | 000 |
| 06945040100294 | K101273 | 000 |