The following data is part of a premarket notification filed by Shenzhen Jumper Medical Equipment Co.,ltd. with the FDA for Wireless Intelligent Thermometer.
Device ID | K182437 |
510k Number | K182437 |
Device Name: | Wireless Intelligent Thermometer |
Classification | Thermometer, Electronic, Clinical |
Applicant | Shenzhen Jumper Medical Equipment Co.,Ltd. D Building, No. 71, Xintian Road, Fuyong Street, Baoan Shenzhen, CN 518100 |
Contact | Tom Tom |
Correspondent | Reanny Wang Shenzhen Reanny Medical Devices Management Consulting Co., L Room 2012#, Gebu Commercial Building, Hongxing Community Songgang Street 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 | 2018-09-07 |
Decision Date | 2019-05-05 |