The following data is part of a premarket notification filed by K-jump Health Co., Ltd. with the FDA for Basal Digital Thermometer.
| Device ID | K141505 |
| 510k Number | K141505 |
| Device Name: | BASAL DIGITAL THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | K-JUMP HEALTH CO., LTD. NO. 56, WU KUNG 5TH RD., NEW TAIPEI INDUST PARK New Taipei, TW 24890 |
| Contact | Jm Lin |
| Correspondent | Jm Lin K-JUMP HEALTH CO., LTD. NO. 56, WU KUNG 5TH RD., NEW TAIPEI INDUST PARK New Taipei, TW 24890 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-06 |
| Decision Date | 2014-08-26 |
| Summary: | summary |