FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
K Number: K251160
·
Decision Jan 8, 2026
Classifications
1
FEI Numbers
488
Registration Numbers
488
Same Product Code
797
Applicant Total
14
Review Days
268
Basic Information
- Device Name
- Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
- K Number
- K251160
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Med-Link Electronics Tech Co., Ltd.
- Date Received
- April 15, 2025
- Decision Date
- January 8, 2026
- Product Code
- FLL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | FDA class 2 | General Hospital |
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