The following data is part of a premarket notification filed by Labarge, Inc. with the FDA for Esophageal Stethoscope.
| Device ID | K771520 |
| 510k Number | K771520 |
| Device Name: | ESOPHAGEAL STETHOSCOPE |
| Classification | Stethoscope, Electronic |
| Applicant | LABARGE, 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 | 1977-08-08 |
| Decision Date | 1977-09-23 |