The following data is part of a premarket notification filed by Guangdong Biolight Meditech Co., Ltd. with the FDA for Digital Electrocardiograph.
| Device ID | K131858 |
| 510k Number | K131858 |
| Device Name: | DIGITAL ELECTROCARDIOGRAPH |
| Classification | Electrocardiograph |
| Applicant | GUANGDONG BIOLIGHT MEDITECH CO., LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong GUANGDONG BIOLIGHT MEDITECH 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 | 2013-06-24 |
| Decision Date | 2014-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852503007198 | K131858 | 000 |
| 00852503007181 | K131858 | 000 |
| 00852503007174 | K131858 | 000 |
| 06932562310225 | K131858 | 000 |
| 06932562310157 | K131858 | 000 |
| 06932562310072 | K131858 | 000 |