Kejump Digital Clinical Thermometer
by K-jump Health Co., Ltd. 510(k)
Active
510(k) K903590
Overview
The Kejump Digital Clinical Thermometer is an electronic device classified as a Thermometer, Electronic, Clinical under FDA regulation 880.2910. It is designed for accurate measurement of body temperature in clinical settings, providing precise readings for patient assessment and monitoring.
This device is intended for single-use or reusable applications in general hospital environments, as determined by its FDA 510(k) clearance (K903590). It adheres to traditional review standards and was granted Substantially Equivalent status in 1990. No third-party certification or additional regulatory markings are specified in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK903590 | Date22 Oct 1990 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FLL
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent