DIVA ZSP2105CMI with QUBYX PerfectLum bundle— 510(k) K160328
Substantially EquivalentThe Linden Group Corp
FDA 510(k) clearance K160328 for DIVA ZSP2105CMI with QUBYX PerfectLum bundle, Substantially Equivalent on 2016-02-25. Applicant: The Linden Group Corp. Device class: 2.
Clearance details
- Applicant
- The Linden Group Corp
- Product code
- Code PGY
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cedar Knolls, NJ, US
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