The following data is part of a premarket notification filed by Braun Gmbh with the FDA for Braun Precision Sensor Pro, Model Bp 2590.
| Device ID | K012035 |
| 510k Number | K012035 |
| Device Name: | BRAUN PRECISION SENSOR PRO, MODEL BP 2590 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | BRAUN GMBH 6183 PASEO DEL MORTE SUITE 150 Carlsbad, CA 92009 |
| Contact | Fred Schlador |
| Correspondent | Fred Schlador BRAUN GMBH 6183 PASEO DEL MORTE SUITE 150 Carlsbad, CA 92009 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-29 |
| Decision Date | 2001-07-27 |
| Summary: | summary |