OEC(R) 9800, OEC(R) 9800 PLUS
FDA 510(k) clearance K111551 · decided 2011-10-04
Clearance details
- K-number
- K111551
- Device name
- OEC(R) 9800, OEC(R) 9800 PLUS
- Applicant
- Ge Oec Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-06-03
- Decision date
- 2011-10-04
- Days to decision
- 123 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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