The following data is part of a premarket notification filed by Guangdong Biolight Meditech Co., Ltd. with the FDA for Electronic Sphygmomanometer.
| Device ID | K160349 |
| 510k Number | K160349 |
| Device Name: | Electronic Sphygmomanometer |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Guangdong Biolight Meditech Co., Ltd. Innovation First Road, Technical Innovation Coast Zhuhai, CN 519085 |
| Contact | Liang Jin |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-08 |
| Decision Date | 2016-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06932562310249 | K160349 | 000 |