FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION
K Number: K041931
·
Decision Aug 26, 2004
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
300
Applicant Total
4
Review Days
38
Basic Information
- Device Name
- OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION
- K Number
- K041931
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GE OEC MEDICAL SYSTEMS, INC.
- Date Received
- July 19, 2004
- Decision Date
- August 26, 2004
- 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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