The following data is part of a premarket notification filed by Sensatronic Gmbh with the FDA for Sensatronic Reusable Temperature Probes.
| Device ID | K203643 |
| 510k Number | K203643 |
| Device Name: | Sensatronic Reusable Temperature Probes |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Sensatronic GmbH Am Ring 9 Wismar, DE 23970 |
| Contact | Jens Schwarz |
| Correspondent | Stephen H. Gorski Imagenix, Inc. S65 W35739 Piper Road Eagle, WI 53119 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-14 |
| Decision Date | 2021-08-11 |