The following data is part of a premarket notification filed by K-jump Health Co., Ltd. with the FDA for Flexible Tip Digital Thermometer.
| Device ID | K974195 |
| 510k Number | K974195 |
| Device Name: | FLEXIBLE TIP DIGITAL THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | K-JUMP HEALTH CO., LTD. 581 CONFERENCE PLACE Golden, CO 80401 |
| Contact | Robert J Zappa |
| Correspondent | Robert J Zappa K-JUMP HEALTH CO., LTD. 581 CONFERENCE PLACE 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 | 1997-11-07 |
| Decision Date | 1998-02-04 |
| Summary: | summary |