OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM
FDA 510(k) clearance K041932 · decided 2004-08-18
Clearance details
- K-number
- K041932
- Device name
- OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM
- Applicant
- Ge Oec Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-07-19
- Decision date
- 2004-08-18
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- OWB
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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