The following data is part of a premarket notification filed by K-jump Health Co., Ltd. with the FDA for K-jump Digital Thermometer With Battery-less Patch, Model Kd-2100.
Device ID | K060240 |
510k Number | K060240 |
Device Name: | K-JUMP DIGITAL THERMOMETER WITH BATTERY-LESS PATCH, MODEL KD-2100 |
Classification | Thermometer, Electronic, Clinical |
Applicant | K-JUMP HEALTH CO., LTD. 55 NORHTERN BLVD. Great Neck, NY 11021 |
Contact | Susan D Goldstein-falk |
Correspondent | Susan D Goldstein-falk K-JUMP HEALTH CO., LTD. 55 NORHTERN BLVD. Great Neck, NY 11021 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-01-31 |
Decision Date | 2006-05-19 |
Summary: | summary |