The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French.
| Device ID | K193027 |
| 510k Number | K193027 |
| Device Name: | Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French |
| Classification | Stethoscope, Esophageal, With Electrical Conductors |
| Applicant | DeRoyal Industries, Inc. 200 DeBusk Lane Powell, TN 37849 |
| Contact | Sarah Bennett |
| Correspondent | Sarah Bennett DeRoyal Industries, Inc. 200 DeBusk Lane Powell, TN 37849 |
| Product Code | BZT |
| CFR Regulation Number | 868.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-30 |
| Decision Date | 2020-04-02 |