The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Model Bps08 Blood Pressure Module.
| Device ID | K881155 |
| 510k Number | K881155 |
| Device Name: | MODEL BPS08 BLOOD PRESSURE MODULE |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | FRESENIUS USA, INC. 4090 PIKE LN. Concord, CA 94520 |
| Contact | Tom Cane |
| Correspondent | Tom Cane FRESENIUS USA, INC. 4090 PIKE LN. Concord, CA 94520 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-18 |
| Decision Date | 1988-07-28 |