Decision Date2023-01-27
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
C2 Xplore is the device name listed in this FDA 510(k) record. The listed applicant is Inomed Medizintechnik GmbH. It received FDA 510(k) clearance on 2023-01-27 under 510(k) number K223254. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the C2 Xplore?
C2 Xplore is a medical device that received FDA 510(k) clearance on 2023-01-27. The listed applicant is Inomed Medizintechnik GmbH. The 510(k) number is K223254.
When did C2 Xplore receive FDA 510(k) clearance?
C2 Xplore received FDA 510(k) clearance on 2023-01-27, under 510(k) number K223254.
Who is the listed applicant for C2 Xplore?
The FDA 510(k) record lists Inomed Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for C2 Xplore?
The FDA product code for C2 Xplore is ETN.
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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.