K940169 is an FDA 510(k) clearance for the DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULTI-PURPOSE ESOPHAGEAL STETHOSCOPE. 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 July 28, 1994, 202 days after receiving the submission on January 7, 1994.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1920.
| 510(k) Number | K940169 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 07, 1994 |
| Decision Date | July 28, 1994 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BZT — Stethoscope, Esophageal, With Electrical Conductors |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1920 |