Micromate Navi+
K-Number: K230130 · 2023-10-10
ApplicantIsys Medizintechnik GmbH
Decision Date2023-10-10
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Micromate Navi+ is a medical device manufactured by Isys Medizintechnik GmbH. It received FDA 510(k) clearance on 2023-10-10 under approval number K230130. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Micromate Navi+?
Micromate Navi+ is a medical device that received FDA 510(k) clearance on 2023-10-10. It is manufactured by Isys Medizintechnik GmbH. The 510(k) number is K230130.
When was Micromate Navi+ approved by the FDA?
Micromate Navi+ received FDA 510(k) clearance on 2023-10-10, under approval number K230130.
What company makes Micromate Navi+?
Micromate Navi+ is manufactured by Isys Medizintechnik GmbH.
What is the FDA product code for Micromate Navi+?
The FDA product code for Micromate Navi+ is JAK.
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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.