FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
X-MAT
K Number: K862144
·
Decision Jun 25, 1986
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
30
Applicant Total
1
Review Days
21
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Basic Information
- Device Name
- X-MAT
- K Number
- K862144
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1980
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Combined Concepts, Inc.
- Date Received
- June 4, 1986
- Decision Date
- June 25, 1986
- Product Code
- KXJ
- 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 |
|---|---|---|---|
| KXJ | Table, Radiologic | FDA class 2 | Radiology |
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