K193027 is an FDA 510(k) clearance for the Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French. This device is classified as a Stethoscope, Esophageal, With Electrical Conductors (Class II - Special Controls, product code BZT).
Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on April 2, 2020, 155 days after receiving the submission on October 30, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1920.
| 510(k) Number | K193027 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2019 |
| Decision Date | April 02, 2020 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZT — Stethoscope, Esophageal, With Electrical Conductors |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1920 |