The following data is part of a premarket notification filed by Integrated Medical Systems, Inc. with the FDA for Ims-2000s Stress Monitor.
| Device ID | K871659 |
| 510k Number | K871659 |
| Device Name: | IMS-2000S STRESS MONITOR |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | INTEGRATED MEDICAL SYSTEMS, INC. 15000 W. 6TH AVE. Golden, CO 80401 |
| Contact | Robert J Stevenson |
| Correspondent | Robert J Stevenson INTEGRATED MEDICAL SYSTEMS, INC. 15000 W. 6TH AVE. Golden, CO 80401 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-28 |
| Decision Date | 1987-05-28 |