FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OEC 9900 ELITE
K Number: K122234
·
Decision Aug 16, 2012
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
319
Applicant Total
3
Review Days
21
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Basic Information
- Device Name
- OEC 9900 ELITE
- K Number
- K122234
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ge Healthcare Surgery GE Oec Medical Systems, Inc.
- Date Received
- July 26, 2012
- Decision Date
- August 16, 2012
- Product Code
- OWB
- 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 |
|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | FDA class 2 | Radiology |
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