The following data is part of a premarket notification filed by Shenzhen Biocare Bio-medical Equipment Co., Ltd. with the FDA for Digital Electrocardiograph.
| Device ID | K132758 |
| 510k Number | K132758 |
| Device Name: | DIGITAL ELECTROCARDIOGRAPH |
| Classification | Electrocardiograph |
| Applicant | SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-04 |
| Decision Date | 2014-01-30 |
| Summary: | summary |