FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM
FDA 510(k) clearance K003837 · decided 2001-03-12
Clearance details
- K-number
- K003837
- Device name
- FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM
- Applicant
- Ge Oec Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2000-12-12
- Decision date
- 2001-03-12
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- OXO
- 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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