FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Kinsa QuickCare Thermometer
K Number: K173730
·
Decision Jan 17, 2018
Classifications
1
FEI Numbers
518
Registration Numbers
518
Same Product Code
795
Applicant Total
1
Review Days
42
Basic Information
- Device Name
- Kinsa QuickCare Thermometer
- K Number
- K173730
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- KINSA, Inc.
- Date Received
- December 6, 2017
- Decision Date
- January 17, 2018
- Product Code
- FLL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- Y
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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