The following data is part of a premarket notification filed by K-jump Health Co., Ltd. with the FDA for Probe Covers For Thermometers.
| Device ID | K180714 |
| 510k Number | K180714 |
| Device Name: | Probe Covers For Thermometers |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | K-jump Health Co., Ltd. No. 56, Wu Kung 5th Rd. New Taipei Industrial Park New Taipei City, TW 24890 |
| 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 24890 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-19 |
| Decision Date | 2018-09-24 |
| Summary: | summary |