The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Foley Catheter With Temperature Sensor.
| Device ID | K200757 |
| 510k Number | K200757 |
| Device Name: | Foley Catheter With Temperature Sensor |
| Classification | Catheter, Upper Urinary Tract |
| 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 | EYC |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-24 |
| Decision Date | 2020-10-15 |