The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Model Im1000 Integrated Monitor.
| Device ID | K810731 |
| 510k Number | K810731 |
| Device Name: | MODEL IM1000 INTEGRATED MONITOR |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | GOULD, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-17 |
| Decision Date | 1981-03-27 |