FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KENTEMP
K Number: K953465
·
Decision Dec 15, 1995
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
32
Applicant Total
6
Review Days
144
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Basic Information
- Device Name
- KENTEMP
- K Number
- K953465
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2920
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Kentron Health Care, Inc.
- Date Received
- July 24, 1995
- Decision Date
- December 15, 1995
- 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
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AMG MED BRAND CLINICAL GLASS THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Kentron Health Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K030693 | KENTEX DISPOSABLE VAGINAL SPECULUM | Aug 27, 2003 | Substantially Equivalent |
| K972410 | IMPERVIOUS ISOLATION GOWN | Sep 19, 1997 | Substantially Equivalent |
| K971917 | KENTRON'S ISOLATION GOWN | Sep 19, 1997 | Substantially Equivalent |
| K953914 | KENTEX | Nov 6, 1995 | Substantially Equivalent |
| K953830 | KENSORB | Oct 3, 1995 | Substantially Equivalent |