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 |