FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MASCOT THERMOTER
K Number: K903500
·
Decision Oct 9, 1990
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
32
Applicant Total
4
Review Days
67
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MASCOT THERMOTER
- K Number
- K903500
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2920
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Mascot, Inc.
- Date Received
- August 3, 1990
- Decision Date
- October 9, 1990
- Product Code
- FLK
- 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 |
|---|---|---|---|
| FLK | Thermometer, Clinical Mercury | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FLK), ordered by most recent decision date.
AMSINO CLINICAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
GERATHERM MERCUIRY FREE CLINICAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
KENTEMP
FDA 510(k)
FDA Class 2
·General Hospital
CLINICAL GLASS THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
MEDIAID UNIVERSAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
AMG MED BRAND CLINICAL GLASS THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital