AcuityDRe— 510(k) K210919
Substantially EquivalentRadmedix, LLC
FDA 510(k) clearance K210919 for AcuityDRe, Substantially Equivalent on 2021-04-30. Applicant: Radmedix, LLC. Device class: 2.
Clearance details
- Applicant
- Radmedix, LLC
- Product code
- Code MQB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dayton, OH, US
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