The following data is part of a premarket notification filed by Schiller Ag with the FDA for Bp-200 Plus.
| Device ID | K063814 |
| 510k Number | K063814 |
| Device Name: | BP-200 PLUS |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SCHILLER AG ALTGASSE 68 Baar, Zg, CH 6341 |
| Contact | Reto Kuettel |
| Correspondent | Reto Kuettel SCHILLER AG ALTGASSE 68 Baar, Zg, 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 | 2006-12-22 |
| Decision Date | 2007-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613365000139 | K063814 | 000 |
| 07613365000122 | K063814 | 000 |