FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes
K Number: K193338
·
Decision Aug 25, 2020
Classifications
1
FEI Numbers
518
Registration Numbers
518
Same Product Code
795
Applicant Total
5
Review Days
267
Basic Information
- Device Name
- Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes
- K Number
- K193338
- 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
- December 2, 2019
- Decision Date
- August 25, 2020
- 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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Other Clearances by Shenzhen Med-link Electronics Tech Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K220448 | Disposable Non-invasive EEG Sensor | Jan 19, 2023 | Substantially Equivalent |
| K220447 | Med-link Disposable ECG Cable and Leadwires | Jun 28, 2022 | Substantially Equivalent |
| K212752 | Med-link Pulse Oximeter | May 20, 2022 | Substantially Equivalent |
| K182667 | Med-link Temperature Probes | Jun 18, 2019 | Substantially Equivalent |