The following data is part of a premarket notification filed by K-jump Health Co., Ltd. with the FDA for Non-contact Thermometer.
| Device ID | K120711 |
| 510k Number | K120711 |
| Device Name: | NON-CONTACT THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | K-JUMP HEALTH CO., LTD. NO. 56, WU KUNG 5TH RD., NEW TAIPEI INDUSTRIAL PARK New Taipei City, TW 248 |
| Contact | Jm Lin |
| Correspondent | Jm Lin K-JUMP HEALTH CO., LTD. NO. 56, WU KUNG 5TH RD., NEW TAIPEI INDUSTRIAL PARK New Taipei City, TW 248 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-08 |
| Decision Date | 2012-11-19 |
| Summary: | summary |