FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
E-Z TEMP II
K Number: K934941
·
Decision Jul 27, 1994
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
20
Applicant Total
1
Review Days
282
Basic Information
- Device Name
- E-Z TEMP II
- K Number
- K934941
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- SEVEN C'S, INC.
- Date Received
- October 18, 1993
- Decision Date
- July 27, 1994
- 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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