The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Debusk Temperature Systems Premier And Signature Series Multi-purpose Esophageal Stethoscope.
| Device ID | K940169 |
| 510k Number | K940169 |
| Device Name: | DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULTI-PURPOSE ESOPHAGEAL STETHOSCOPE |
| Classification | Stethoscope, Esophageal, With Electrical Conductors |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Debra F Manning |
| Correspondent | Debra F Manning DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. 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 | 1994-01-07 |
| Decision Date | 1994-07-28 |