The following data is part of a premarket notification filed by Ningbo Ranor Medical Science & Technology Co., Ltd. with the FDA for Infrared Thermometer Model Number Rn-50a,rn-50b.
| Device ID | K200578 |
| 510k Number | K200578 |
| Device Name: | Infrared Thermometer Model Number RN-50A,RN-50B |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Ningbo Ranor Medical Science & Technology Co., Ltd. No. 127 Fenghui Road, Wangchun Industrial Park, Haishu District Ningbo, CN 315000 |
| Contact | Emma Hu |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738,Shangcheng Rd., Pudong Shanghai, CN 200120 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-05 |
| Decision Date | 2020-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859811009241 | K200578 | 000 |
| 06934832600586 | K200578 | 000 |
| 06934832600517 | K200578 | 000 |