The following data is part of a premarket notification filed by Kangfu Medical Equipment Factory with the FDA for Cocet Digital Thermometer (models Kft-01/kft-02/kft-03/kft-04/kft-05/kft-06/kft-07/kft-08/kft-09/kft-10.
| Device ID | K182652 |
| 510k Number | K182652 |
| Device Name: | COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Kangfu Medical Equipment Factory No. 380 Ningkang East Road Yueqing City, CN 325600 |
| Contact | Zelong Cao |
| Correspondent | Zelong Cao Kangfu Medical Equipment Factory No. 380 Ningkang East Road Yueqing City, CN 325600 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-24 |
| Decision Date | 2018-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08719699631472 | K182652 | 000 |
| 08719699631465 | K182652 | 000 |
| 08719699631458 | K182652 | 000 |
| 08719699631113 | K182652 | 000 |
| 00860004898603 | K182652 | 000 |