The following data is part of a premarket notification filed by Guangdong Biolight Meditech Co., Ltd with the FDA for Fetal Monitors.
| Device ID | K131941 |
| 510k Number | K131941 |
| Device Name: | FETAL MONITORS |
| Classification | System, Monitoring, Perinatal |
| Applicant | GUANGDONG BIOLIGHT MEDITECH CO., LTD P.O. BOX 120-119 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong GUANGDONG BIOLIGHT MEDITECH CO., LTD P.O. BOX 120-119 Shanghai, CN 200237 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-27 |
| Decision Date | 2014-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852503007211 | K131941 | 000 |
| 00852503007204 | K131941 | 000 |
| 06932562310294 | K131941 | 000 |
| 06932562310287 | K131941 | 000 |
| 06932562310270 | K131941 | 000 |
| 06932562310263 | K131941 | 000 |