The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Model Sa-1 Stethoscope Audio Amplifier.
| Device ID | K823126 |
| 510k Number | K823126 |
| Device Name: | MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER |
| Classification | Stethoscope, Esophageal |
| Applicant | ELECTROMEDICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZW |
| CFR Regulation Number | 868.1910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-25 |
| Decision Date | 1982-11-16 |