The following data is part of a premarket notification filed by Shenzhen Biocare Electronics Co., Ltd with the FDA for Digital Electrocardiograph, Models Ecg-1210, Ecg-1230, Ecg-3010, Ecg-6010.
| Device ID | K101876 |
| 510k Number | K101876 |
| Device Name: | DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010 |
| Classification | Electrocardiograph |
| Applicant | SHENZHEN BIOCARE ELECTRONICS CO., LTD SUITE 5D, NO 19, LANE 999 ZHONGSHAN NO. 2 ROAD(S) Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong SHENZHEN BIOCARE ELECTRONICS CO., LTD SUITE 5D, NO 19, LANE 999 ZHONGSHAN NO. 2 ROAD(S) Shanghai, CN 200030 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-06 |
| Decision Date | 2011-03-01 |
| Summary: | summary |