The following data is part of a premarket notification filed by Guangdong Transtek Medical Electronics Co., Ltd with the FDA for Transtek Blood Pressure Monitor.
| Device ID | K131395 |
| 510k Number | K131395 |
| Device Name: | TRANSTEK BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD NO.1 FANGHUA STREET, HI-TECH DISTRICT Chengdu, Sichuan, CN 610041 |
| Contact | Leo Wang |
| Correspondent | Leo Wang GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD NO.1 FANGHUA STREET, HI-TECH DISTRICT Chengdu, Sichuan, CN 610041 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-15 |
| Decision Date | 2013-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00075020056382 | K131395 | 000 |
| 10875011006047 | K131395 | 000 |
| 10858069007044 | K131395 | 000 |
| 04719878120012 | K131395 | 000 |
| 34719878120020 | K131395 | 000 |
| 30860002249699 | K131395 | 000 |
| 10875011006344 | K131395 | 000 |
| 10810038632565 | K131395 | 000 |