SIMPLEABI— 510(k) K110628
Substantially EquivalentNewman Medical
FDA 510(k) clearance K110628 for SIMPLEABI, Substantially Equivalent on 2011-05-12. Applicant: Newman Medical. Device class: 2.
Clearance details
- Applicant
- Newman Medical
- Product code
- Code JAF
- Device class
- Class 2
- Regulation
- 21 CFR 892.1540
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arvada, CO, US
Recent devices under product code JAF
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