The following data is part of a premarket notification filed by Biomedical Concepts, Inc. with the FDA for Lifesound Esophageal Stethoscope.
| Device ID | K811928 |
| 510k Number | K811928 |
| Device Name: | LIFESOUND ESOPHAGEAL STETHOSCOPE |
| Classification | Stethoscope, Esophageal, With Electrical Conductors |
| Applicant | BIOMEDICAL CONCEPTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BZT |
| CFR Regulation Number | 868.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-06 |
| Decision Date | 1981-07-28 |