The following data is part of a premarket notification filed by Biocare Asia Corporation Ltd. with the FDA for Hd Blood Pressure Monitor.
| Device ID | K141924 |
| 510k Number | K141924 |
| Device Name: | HD BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | BIOCARE ASIA CORPORATION LTD. NO. 260, MAYUN ROAD NEW DISTRICT Suzhou, Jiangsu, CN 215129 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen BIOCARE ASIA CORPORATION LTD. NO. 260, MAYUN ROAD NEW DISTRICT Suzhou, Jiangsu, CN 215129 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-16 |
| Decision Date | 2014-09-08 |
| Summary: | summary |