DIVA ZSP2105CMI with QUBYX PerfectLum bundle
K-Number: K160328 · 2016-02-25
ApplicantThe Linden Group Corp
Decision Date2016-02-25
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
DIVA ZSP2105CMI with QUBYX PerfectLum bundle is a medical device manufactured by The Linden Group Corp. It received FDA 510(k) clearance on 2016-02-25 under approval number K160328. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DIVA ZSP2105CMI with QUBYX PerfectLum bundle?
DIVA ZSP2105CMI with QUBYX PerfectLum bundle is a medical device that received FDA 510(k) clearance on 2016-02-25. It is manufactured by The Linden Group Corp. The 510(k) number is K160328.
When was DIVA ZSP2105CMI with QUBYX PerfectLum bundle approved by the FDA?
DIVA ZSP2105CMI with QUBYX PerfectLum bundle received FDA 510(k) clearance on 2016-02-25, under approval number K160328.
What company makes DIVA ZSP2105CMI with QUBYX PerfectLum bundle?
DIVA ZSP2105CMI with QUBYX PerfectLum bundle is manufactured by The Linden Group Corp.
What is the FDA product code for DIVA ZSP2105CMI with QUBYX PerfectLum bundle?
The FDA product code for DIVA ZSP2105CMI with QUBYX PerfectLum bundle is PGY.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.