16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)— 510(k) K244054
Substantially EquivalentQuality Electrodynamics
FDA 510(k) clearance K244054 for 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247), Substantially Equivalent on 2025-02-28. Applicant: Quality Electrodynamics. Device class: 2.
Clearance details
- Applicant
- Quality Electrodynamics
- Product code
- Code MOS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mayfield Village, OH, US
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