The following data is part of a premarket notification filed by K-jump Health Co., Ltd. with the FDA for Digital Forehead Thermometer.
| Device ID | K103617 |
| 510k Number | K103617 |
| Device Name: | DIGITAL FOREHEAD THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | K-JUMP HEALTH CO., LTD. NO. 56, WU KUNG 5TH RD., WU KU INDUSTRIAL PARK Taipei Hsien, TW 248 |
| Contact | Jason Cheng |
| Correspondent | Jason Cheng K-JUMP HEALTH CO., LTD. NO. 56, WU KUNG 5TH RD., WU KU INDUSTRIAL PARK Taipei Hsien, TW 248 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-10 |
| Decision Date | 2011-04-04 |
| Summary: | summary |