The following data is part of a premarket notification filed by Intersect Systems, Inc. with the FDA for Dif-stet.
| Device ID | K832882 |
| 510k Number | K832882 |
| Device Name: | DIF-STET |
| Classification | Stethoscope, Electronic |
| Applicant | INTERSECT SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-26 |
| Decision Date | 1983-12-06 |