The following data is part of a premarket notification filed by Shenzhen Belter Health Measurement And Analysis Te with the FDA for Belter Blood Pressure Meter.
| Device ID | K134029 |
| 510k Number | K134029 |
| Device Name: | BELTER BLOOD PRESSURE METER |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE 702, 704 BLOCK C, TSINGHUA UNIS SCIENCE PARK NO. 13 LANGSHAN RD HI-TECH IND Shenzhen, Guangdong, CN 518057 |
| Contact | Pang Ming |
| Correspondent | Pang Ming SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE 702, 704 BLOCK C, TSINGHUA UNIS SCIENCE PARK NO. 13 LANGSHAN RD HI-TECH IND Shenzhen, Guangdong, CN 518057 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-31 |
| Decision Date | 2014-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854067005252 | K134029 | 000 |
| 06947468500342 | K134029 | 000 |
| 16947468500202 | K134029 | 000 |
| 16947468500080 | K134029 | 000 |
| 06947468500168 | K134029 | 000 |
| 16947468589009 | K134029 | 000 |
| 06947468535665 | K134029 | 000 |
| 06947468535672 | K134029 | 000 |
| 26947468535713 | K134029 | 000 |
| 26947468535720 | K134029 | 000 |
| 16947468535778 | K134029 | 000 |
| 06947468555069 | K134029 | 000 |
| 16947468500295 | K134029 | 000 |