The following data is part of a premarket notification filed by Sunray Medical Apparatus Co., Ltd. with the FDA for Sunray Fetal Monitor.
| Device ID | K123335 |
| 510k Number | K123335 |
| Device Name: | SUNRAY FETAL MONITOR |
| Classification | System, Monitoring, Perinatal |
| Applicant | SUNRAY MEDICAL APPARATUS CO., LTD. B102 NANSHAN MEDICAL DEVICES INDUSTRIAL PARK, NO. 1019 OF NANHAI AVE Shenzhen, Guangdong, CN 518067 |
| Contact | Sabrina Wei |
| Correspondent | Sabrina Wei SUNRAY MEDICAL APPARATUS CO., LTD. B102 NANSHAN MEDICAL DEVICES INDUSTRIAL PARK, NO. 1019 OF NANHAI AVE Shenzhen, Guangdong, CN 518067 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-26 |
| Decision Date | 2013-03-21 |
| Summary: | summary |