FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICAL C-ARM TABLE, 9610
K Number: K953557
·
Decision Sep 26, 1995
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
76
Applicant Total
4
Review Days
71
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Basic Information
- Device Name
- SURGICAL C-ARM TABLE, 9610
- K Number
- K953557
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1980
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- U.S. Imaging Tables, Inc.
- Date Received
- July 17, 1995
- Decision Date
- September 26, 1995
- Product Code
- IXR
- 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 |
|---|---|---|---|
| IXR | Table, Radiographic, Tilting | FDA class 2 | Radiology |
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