FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DESERET INSYTE HYPERTHERMIA CATHETER
K Number: K821886
·
Decision Jul 28, 1982
Classifications
1
FEI Numbers
488
Registration Numbers
488
Same Product Code
797
Applicant Total
50
Review Days
33
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Basic Information
- Device Name
- DESERET INSYTE HYPERTHERMIA CATHETER
- K Number
- K821886
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Warner-Lambert Co.
- Date Received
- June 25, 1982
- Decision Date
- July 28, 1982
- Product Code
- FLL
- 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 |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | FDA class 2 | General Hospital |
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