FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Fever Scout Continuous Monitoring thermometer
K Number: K162137
·
Decision Jan 19, 2017
Classifications
1
FEI Numbers
518
Registration Numbers
518
Same Product Code
795
Applicant Total
2
Review Days
171
Basic Information
- Device Name
- Fever Scout Continuous Monitoring thermometer
- K Number
- K162137
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- VivaLnk Inc.
- Date Received
- August 1, 2016
- Decision Date
- January 19, 2017
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FLL), ordered by most recent decision date.
Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)
FDA 510(k)
FDA Class 2
·General Hospital
Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)
FDA 510(k)
FDA Class 2
·General Hospital
YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
FDA 510(k)
FDA Class 2
·General Hospital
Infrared Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
AION TempShield
FDA 510(k)
FDA Class 2
·General Hospital
Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by VivaLnk Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K181013 | Fever Scout | Aug 21, 2018 | Substantially Equivalent |