The following data is part of a premarket notification filed by Hangzhou Hua'an Medical & Health Instruments Co., with the FDA for Upperarm Digital Blood Pressure Monitor, Model: Mb-300 Series.
| Device ID | K092514 |
| 510k Number | K092514 |
| Device Name: | UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., BLDG 2, BAIMIAO IND. PARK ECONOMIC DEVELOPMENT ZONE Wuchang, Hangzhou, Zhejiang, CN 310023 |
| Contact | Ji Bo |
| Correspondent | Ji Bo HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., BLDG 2, BAIMIAO IND. PARK ECONOMIC DEVELOPMENT ZONE Wuchang, Hangzhou, Zhejiang, CN 310023 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-17 |
| Decision Date | 2009-12-04 |