The following data is part of a premarket notification filed by Rudolf Riester Gmbh with the FDA for Ri-former Predictive Thermometer.
| Device ID | K171182 |
| 510k Number | K171182 |
| Device Name: | Ri-former Predictive Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Rudolf Riester GmbH P.O.B. 35, Bruckstraße 31 Junginge, DE De-72417 |
| Contact | Artur Pfister |
| Correspondent | Mike Gu Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 7th Floor, Jingui Business Building No.982 Congyun Rd, Baiyun District Guangzhou, CN 510420 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-24 |
| Decision Date | 2017-10-04 |
| Summary: | summary |