The following data is part of a premarket notification filed by Shenzhen Finicare Co., Ltd. with the FDA for Infrared Thermometer.
| Device ID | K181215 |
| 510k Number | K181215 |
| Device Name: | Infrared Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Shenzhen Finicare Co., Ltd. Room201, A Building NO. 1 Qianwan Road Shengang Cooperative Zone, Qianhai Shenzhen, CN 518052 |
| Contact | Chao Li |
| Correspondent | Chao Li Shenzhen Finicare Co., Ltd. Room201, A Building NO. 1 Qianwan Road Shengang Cooperative Zone, Qianhai Shenzhen, CN 518052 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-07 |
| Decision Date | 2019-01-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001532746 | K181215 | 000 |
| 06971522820169 | K181215 | 000 |
| 10850632007345 | K181215 | 000 |
| 00810477022876 | K181215 | 000 |
| 00898302141886 | K181215 | 000 |
| 00810477022180 | K181215 | 000 |
| 00810477022852 | K181215 | 000 |
| 00850020077090 | K181215 | 000 |
| 00688267567841 | K181215 | 000 |
| 00810477023651 | K181215 | 000 |
| 06971522820220 | K181215 | 000 |
| 06971522820213 | K181215 | 000 |
| 06971522820084 | K181215 | 000 |
| 06971522820008 | K181215 | 000 |
| 06971522820176 | K181215 | 000 |
| 06971522820015 | K181215 | 000 |
| 08719699633124 | K181215 | 000 |
| 08719699632257 | K181215 | 000 |
| 08719699632240 | K181215 | 000 |
| 06971522820138 | K181215 | 000 |
| 06971522820121 | K181215 | 000 |
| 06971522820114 | K181215 | 000 |
| 06971522820107 | K181215 | 000 |
| 06971522820091 | K181215 | 000 |
| 06971522820060 | K181215 | 000 |
| 06971522820053 | K181215 | 000 |
| 06971522820039 | K181215 | 000 |
| 06971522820022 | K181215 | 000 |
| 06971522820077 | K181215 | 000 |