The following data is part of a premarket notification filed by Robert Bosch Healthcare Systems, Inc. with the FDA for Bosch Blood Pressure Meter (bp5000 Bt).
| Device ID | K131026 |
| 510k Number | K131026 |
| Device Name: | BOSCH BLOOD PRESSURE METER (BP5000 BT) |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ROBERT BOSCH HEALTHCARE SYSTEMS, INC. 2400 Geng Rd Ste 200 Palo Alto, CA 94303 |
| Contact | Louise Musante |
| Correspondent | Louise Musante ROBERT BOSCH HEALTHCARE SYSTEMS, INC. 2400 Geng Rd Ste 200 Palo Alto, CA 94303 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-12 |
| Decision Date | 2013-11-14 |
| Summary: | summary |