The following data is part of a premarket notification filed by Contec Medical System Co., Ltd. with the FDA for Single-channel Handheld Electrocardiograph, Model Ecg80a.
| Device ID | K090936 |
| 510k Number | K090936 |
| Device Name: | SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A |
| Classification | Electrocardiograph |
| Applicant | CONTEC MEDICAL SYSTEM CO., LTD. SUITE 8D , ZHONGXIN ZHONGSHAN MANSION, NO. 19, LANE 999, Zhong Shan, Shanghai, CN 20030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong CONTEC MEDICAL SYSTEM CO., LTD. SUITE 8D , ZHONGXIN ZHONGSHAN MANSION, NO. 19, LANE 999, Zhong Shan, Shanghai, CN 20030 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-02 |
| Decision Date | 2009-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945040100065 | K090936 | 000 |