FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OMNI THERM TEMPERATURE MONITOR
K Number: K864853
·
Decision Feb 4, 1987
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
20
Applicant Total
5
Review Days
55
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Basic Information
- Device Name
- OMNI THERM TEMPERATURE MONITOR
- K Number
- K864853
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Omni Therm, Inc.
- Date Received
- December 11, 1986
- Decision Date
- February 4, 1987
- Product Code
- KPD
- 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 |
|---|---|---|---|
| KPD | Strip, Temperature, Forehead, Liquid Crystal | FDA class 2 | General Hospital |
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