FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
C-TRAK BIOPSY SYSTEM
K Number: K922117
·
Decision Oct 14, 1992
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
29
Applicant Total
4
Review Days
162
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Basic Information
- Device Name
- C-TRAK BIOPSY SYSTEM
- K Number
- K922117
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1320
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Care Wise Medical Products Corp.
- Date Received
- May 5, 1992
- Decision Date
- October 14, 1992
- 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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