Decision Date2024-03-08
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
RESCAN 700 is a medical device manufactured by Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2024-03-08 under approval number K233421. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the RESCAN 700?
RESCAN 700 is a medical device that received FDA 510(k) clearance on 2024-03-08. It is manufactured by Carl Zeiss Meditec, AG. The 510(k) number is K233421.
When was RESCAN 700 approved by the FDA?
RESCAN 700 received FDA 510(k) clearance on 2024-03-08, under approval number K233421.
What company makes RESCAN 700?
RESCAN 700 is manufactured by Carl Zeiss Meditec, AG.
What is the FDA product code for RESCAN 700?
The FDA product code for RESCAN 700 is OBO.
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Official Source
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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.