The following data is part of a premarket notification filed by Zhongshan Transtek Electronics Co., Ltd. with the FDA for Transtek Blood Pressure Monitor.
| Device ID | K120058 |
| 510k Number | K120058 |
| Device Name: | TRANSTEK BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. NO. 1 FANGHUA STREET HI-TECH DISTRICT Chengdu, CN 610041 |
| Contact | Leo Wang |
| Correspondent | Leo Wang ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. NO. 1 FANGHUA STREET HI-TECH DISTRICT Chengdu, 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 | 2012-01-09 |
| Decision Date | 2012-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817746020120 | K120058 | 000 |
| 00875011006323 | K120058 | 000 |
| 00875011006620 | K120058 | 000 |
| 10850023727029 | K120058 | 000 |
| 00817915020173 | K120058 | 000 |
| 04897106770045 | K120058 | 000 |
| 00860002249681 | K120058 | 000 |
| 00817915020159 | K120058 | 000 |
| 00810038630175 | K120058 | 000 |
| 06972797030116 | K120058 | 000 |
| 00850003180090 | K120058 | 000 |
| 00860001625806 | K120058 | 000 |
| 06971508420000 | K120058 | 000 |
| 00863696000309 | K120058 | 000 |
| 10875011006009 | K120058 | 000 |
| 10875011006023 | K120058 | 000 |
| 00817746020090 | K120058 | 000 |
| 10810038636266 | K120058 | 000 |