OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM
FDA 510(k) clearance K021049 · decided 2002-04-17
Clearance details
- K-number
- K021049
- Device name
- OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM
- Applicant
- Ge Oec Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2002-04-01
- Decision date
- 2002-04-17
- Days to decision
- 16 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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