The following data is part of a premarket notification filed by K-jump Health Co., Ltd. with the FDA for Digital Thermometer.
Device ID | K170262 |
510k Number | K170262 |
Device Name: | Digital Thermometer |
Classification | Thermometer, Electronic, Clinical |
Applicant | K-Jump Health Co., Ltd. No. 56, Wu Kung 5th Rd., New Taipei Industrial Park New Taipei City, TW 24890 |
Contact | Jm Lin |
Correspondent | Jm Lin K-Jump Health Co., Ltd. No. 56, Wu Kung 5th Rd., New Taipei Industrial Park New Taipei City, TW 24890 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-01-27 |
Decision Date | 2017-09-28 |
Summary: | summary |