OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM
FDA 510(k) clearance K024012 · decided 2003-03-20
Clearance details
- K-number
- K024012
- Device name
- OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM
- Applicant
- Ge Oec Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2002-12-04
- Decision date
- 2003-03-20
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- JAA
- 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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