The following data is part of a premarket notification filed by Progressive Technology, Inc. with the FDA for Amplitone-3.
| Device ID | K812676 |
| 510k Number | K812676 |
| Device Name: | AMPLITONE-3 |
| Classification | Stethoscope, Manual |
| Applicant | PROGRESSIVE TECHNOLOGY, INC. 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 | 1981-09-22 |
| Decision Date | 1981-10-13 |