The following data is part of a premarket notification filed by Microlife Intellectual Property Gmbh with the FDA for Microlife Wrist Watch Blood Pressure Monitor, Model Bp3bs1-3c.
| Device ID | K092456 |
| 510k Number | K092456 |
| Device Name: | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BS1-3C |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | MICROLIFE INTELLECTUAL PROPERTY GMBH MDI CONSULTANTS, INC. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk MICROLIFE INTELLECTUAL PROPERTY GMBH MDI CONSULTANTS, INC. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-10 |
| Decision Date | 2009-10-23 |
| Summary: | summary |