The following data is part of a premarket notification filed by K-jump Health Co., Ltd. with the FDA for Digital Clinical Thermometer, Model Kd-193.
| Device ID | K021851 |
| 510k Number | K021851 |
| Device Name: | DIGITAL CLINICAL THERMOMETER, MODEL KD-193 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | K-JUMP HEALTH CO., LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan K-JUMP HEALTH CO., LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 -1109 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-05 |
| Decision Date | 2002-07-17 |
| Summary: | summary |