The following data is part of a premarket notification filed by Orantech Inc. with the FDA for Temperature Probe.
| Device ID | K173194 |
| 510k Number | K173194 |
| Device Name: | Temperature Probe |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Orantech Inc. Zone#A,4F,1st Bld,7th Industrial Zone Yulv Community, GongMing Guangming New District, Shenzhen, CN 518106 |
| Contact | Hsin Xiong |
| Correspondent | Kevin Wang Chonconn Medical Device Consulting Co., Ltd. 22A, Haijing Square, No. 18, Taizi Road Nanshan District, Shenzhen, CN 518067 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-02 |
| Decision Date | 2018-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970706366547 | K173194 | 000 |
| 06941691974659 | K173194 | 000 |
| 06941691974666 | K173194 | 000 |
| 06941691975045 | K173194 | 000 |
| 06941691975052 | K173194 | 000 |
| 06941691975069 | K173194 | 000 |
| 06941691973690 | K173194 | 000 |
| 06970706366509 | K173194 | 000 |
| 06970706366653 | K173194 | 000 |
| 06970706366691 | K173194 | 000 |
| 06941691974406 | K173194 | 000 |