XPLAN 2.1— 510(k) K001700
Substantially EquivalentRadionics, Inc.
FDA 510(k) clearance K001700 for XPLAN 2.1, Substantially Equivalent on 2000-06-28. Applicant: Radionics, Inc.. Device class: 2.
Clearance details
- Applicant
- Radionics, Inc.
- Product code
- Code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Burlington, MA, US
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