The following data is part of a premarket notification filed by Schiller Ag with the FDA for Br 102 Plus Blood Pressure Holter System.
| Device ID | K051368 |
| 510k Number | K051368 |
| Device Name: | BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SCHILLER AG ALTGASSE 68 Baar, CH Ch-6341 |
| Contact | Markus Buetler |
| Correspondent | Markus Buetler SCHILLER AG ALTGASSE 68 Baar, CH Ch-6341 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-25 |
| Decision Date | 2005-08-09 |
| Summary: | summary |