The following data is part of a premarket notification filed by Contec Medical System Co., Ltd. with the FDA for Contec Electrocardiograph.
| Device ID | K131900 |
| 510k Number | K131900 |
| Device Name: | CONTEC ELECTROCARDIOGRAPH |
| Classification | Electrocardiograph |
| Applicant | CONTEC MEDICAL SYSTEM CO., LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong CONTEC MEDICAL SYSTEM 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 | 2013-06-25 |
| Decision Date | 2014-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945040100492 | K131900 | 000 |
| 06945040100089 | K131900 | 000 |
| 06945040100072 | K131900 | 000 |
| 06945040105756 | K131900 | 000 |