The following data is part of a premarket notification filed by Medical Horizons Co. with the FDA for Palpation Enhancer.
| Device ID | K801811 |
| 510k Number | K801811 |
| Device Name: | PALPATION ENHANCER |
| Classification | Stethoscope, Manual |
| Applicant | MEDICAL HORIZONS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LDE |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-08 |
| Decision Date | 1980-09-09 |