FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMPAX 90/15E
K Number: K954356
·
Decision Oct 7, 1995
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
76
Applicant Total
254
Review Days
19
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Basic Information
- Device Name
- COMPAX 90/15E
- K Number
- K954356
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1980
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- General Electric Co.
- Date Received
- September 18, 1995
- Decision Date
- October 7, 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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VISION R/F TILTING TABLE
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PHILIPS EASY DIAGNOST
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ELECTROPHYSIOLOGY TILT TABLE MODEL #9660
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FLUOROVIEW SERIES FLUOROSCOPIC TABLES
FDA 510(k)
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