The following data is part of a premarket notification filed by Sphygmetrics, Inc. with the FDA for Infrasonde D4000 Electronic B-p Monitor.
| Device ID | K800401 |
| 510k Number | K800401 |
| Device Name: | INFRASONDE D4000 ELECTRONIC B-P MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SPHYGMETRICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-26 |
| Decision Date | 1980-03-12 |