FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KOORDINAT M
K Number: K951176
·
Decision Apr 20, 1995
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
76
Applicant Total
519
Review Days
36
Basic Information
- Device Name
- KOORDINAT M
- K Number
- K951176
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1980
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SIEMENS MEDICAL SOLUTIONS USA, INC.
- Date Received
- March 15, 1995
- Decision Date
- April 20, 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 |
Similar 510(k) Clearances
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ELECTROPHYSIOLOGY TILT TABLE MODEL #9660
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FLUOROVIEW SERIES FLUOROSCOPIC TABLES
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