The following data is part of a premarket notification filed by Shenzhen Launch Electrical Co., Ltd with the FDA for Disposable Temperature Probe.
| Device ID | K181967 |
| 510k Number | K181967 |
| Device Name: | Disposable Temperature Probe |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Shenzhen Launch Electrical Co., LTD No.F Building, Zhonggangxing Industrial Estate, Zhangge Community, Guanlan Shenzhen, CN 518110 |
| Contact | Jiaan Huang |
| Correspondent | Tracy Che Feiying Drug & Medical Consulting Technical Service Group B-3F-3005, Bldg.1, Southward Ruifeng Business Center, No.22 Guimiao Rd. Shenzhen, CN 518000 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-23 |
| Decision Date | 2018-12-10 |
| Summary: | summary |