The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Automated Non-invasive Pressure Module.
| Device ID | K840909 |
| 510k Number | K840909 |
| Device Name: | AUTOMATED NON-INVASIVE PRESSURE MODULE |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | GOULD, 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 | 1984-02-29 |
| Decision Date | 1984-06-15 |