MobileX Portable X-ray System— 510(k) K180561
Substantially EquivalentDenterprise International, Inc.
FDA 510(k) clearance K180561 for MobileX Portable X-ray System, Substantially Equivalent on 2018-04-04. Applicant: Denterprise International, Inc.. Device class: 2.
Clearance details
- Applicant
- Denterprise International, Inc.
- Product code
- Code EHD
- Device class
- Class 2
- Regulation
- 21 CFR 872.1800
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ormond Beach, FL, US
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