PORTABLE X-RAY SYSTEM, MODEL DXR -1— 510(k) K082875
Substantially EquivalentExaro Co., Ltd.
FDA 510(k) clearance K082875 for PORTABLE X-RAY SYSTEM, MODEL DXR -1, Substantially Equivalent on 2009-02-05. Applicant: Exaro Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Exaro Co., Ltd.
- 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
- Salt Lake City, UT, US
Recent devices under product code EHD
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