The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Gould-statham Sp1405 Pressure Monitor.
| Device ID | K780798 |
| 510k Number | K780798 |
| Device Name: | GOULD-STATHAM SP1405 PRESSURE MONITOR |
| Classification | Computer, Blood-pressure |
| Applicant | GOULD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DSK |
| CFR Regulation Number | 870.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-05-15 |
| Decision Date | 1978-06-13 |