Visalis V500, Visalis S500
K-Number: K193376 · 2020-06-15
ApplicantCarl Zeiss Meditec, AG
Decision Date2020-06-15
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
Visalis V500, Visalis S500 is a medical device manufactured by Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2020-06-15 under approval number K193376. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Visalis V500, Visalis S500?
Visalis V500, Visalis S500 is a medical device that received FDA 510(k) clearance on 2020-06-15. It is manufactured by Carl Zeiss Meditec, AG. The 510(k) number is K193376.
When was Visalis V500, Visalis S500 approved by the FDA?
Visalis V500, Visalis S500 received FDA 510(k) clearance on 2020-06-15, under approval number K193376.
What company makes Visalis V500, Visalis S500?
Visalis V500, Visalis S500 is manufactured by Carl Zeiss Meditec, AG.
What is the FDA product code for Visalis V500, Visalis S500?
The FDA product code for Visalis V500, Visalis S500 is HQC.
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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.