FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ONCOPROBE II SYSTEM
K Number: K896588
·
Decision Mar 14, 1990
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
29
Applicant Total
4
Review Days
113
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Basic Information
- Device Name
- ONCOPROBE II SYSTEM
- K Number
- K896588
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1320
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Care Wise Medical Products Corp.
- Date Received
- November 21, 1989
- Decision Date
- March 14, 1990
- Product Code
- IZD
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IZD | Probe, Uptake, Nuclear | FDA class 1 | Radiology |
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