FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REI-90/90 RADIOGRAPHIC TABLE
K Number: K854478
·
Decision Apr 17, 1986
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
76
Applicant Total
4
Review Days
161
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Basic Information
- Device Name
- REI-90/90 RADIOGRAPHIC TABLE
- K Number
- K854478
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1980
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Radiological Engineering, Inc.
- Date Received
- November 7, 1985
- Decision Date
- April 17, 1986
- 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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