Flex Body Speeder
FDA 510(k) clearance K200477 · decided 2020-04-08
Clearance details
- K-number
- K200477
- Device name
- Flex Body Speeder
- Applicant
- Quality Electrodynamics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-02-27
- Decision date
- 2020-04-08
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- MOS
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mayfield Heights, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.