The following data is part of a premarket notification filed by Microlife Corp. with the FDA for Microlife Wrist Watch Blood Pressure Monitor, Model Bp-3bu1.
| Device ID | K001182 |
| 510k Number | K001182 |
| Device Name: | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | MICROLIFE CORP. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk MICROLIFE CORP. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-11 |
| Decision Date | 2000-08-01 |