The following data is part of a premarket notification filed by Degania Silicone, Ltd. with the FDA for Temperature Sensor Catheter.
| Device ID | K131020 |
| 510k Number | K131020 |
| Device Name: | TEMPERATURE SENSOR CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | DEGANIA SILICONE, LTD. KIBBUTZ DEGANIA BET Israel, IL 15130 |
| Contact | Zoya Lee |
| Correspondent | Zoya Lee DEGANIA SILICONE, LTD. KIBBUTZ DEGANIA BET Israel, IL 15130 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-12 |
| Decision Date | 2013-05-09 |