The following data is part of a premarket notification filed by Bioland Technology Ltd. with the FDA for Bioland Blood Pressure Monitor.
| Device ID | K083681 |
| 510k Number | K083681 |
| Device Name: | BIOLAND BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | BIOLAND TECHNOLOGY LTD. BLK C, G/F, MING CT., 19-23 MING YUEN W. ST. North Point, HK |
| Contact | David Lee |
| Correspondent | Morten S Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-12-12 |
| Decision Date | 2009-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16939184610129 | K083681 | 000 |