FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTROPHYSIOLOGY TILT TABLE MODEL #9660
K Number: K965105
·
Decision Jan 30, 1997
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
76
Applicant Total
4
Review Days
41
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Basic Information
- Device Name
- ELECTROPHYSIOLOGY TILT TABLE MODEL #9660
- K Number
- K965105
- 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
- December 20, 1996
- Decision Date
- January 30, 1997
- 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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