The following data is part of a premarket notification filed by K-jump Health Co., Ltd. with the FDA for Talking Digital Thermometer, Model Kv-171.
| Device ID | K984553 |
| 510k Number | K984553 |
| Device Name: | TALKING DIGITAL THERMOMETER, MODEL KV-171 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | K-JUMP HEALTH CO., LTD. 720 CORPORATE CIRCLE, SUITE R Golden, CO 80401 |
| Contact | Robert J Zappa |
| Correspondent | Robert J Zappa K-JUMP HEALTH CO., LTD. 720 CORPORATE CIRCLE, SUITE R Golden, CO 80401 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-22 |
| Decision Date | 1999-01-14 |
| Summary: | summary |