The following data is part of a premarket notification filed by Shenzhen Changkun Technology Co., Ltd. with the FDA for Infrared Thermometer, Model Number Ck-t1501, Ck-t1502, Ck-t1503.
| Device ID | K193253 |
| 510k Number | K193253 |
| Device Name: | Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Shenzhen Changkun Technology Co., Ltd. 801, 3F, B Building, NO. 69, Zhenbi Road Biling Community, Pingshan District Shenzhen, CN 518118 |
| Contact | Steve Li |
| Correspondent | Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District Guangzhou, CN 510000 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-18 |
| Decision Date | 2020-06-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850632007598 | K193253 | 000 |
| 00850024759114 | K193253 | 000 |
| 06972040111166 | K193253 | 000 |
| 06951727601459 | K193253 | 000 |