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FDA 510(k)

MICROMATE

K-Number: K203720 · 2021-06-22

ApplicantIsys Medizintechnik GmbH
Decision Date2021-06-22
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MICROMATE is a medical device manufactured by Isys Medizintechnik GmbH. It received FDA 510(k) clearance on 2021-06-22 under approval number K203720. 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?

MICROMATE is a medical device that received FDA 510(k) clearance on 2021-06-22. It is manufactured by Isys Medizintechnik GmbH. The 510(k) number is K203720.

When was MICROMATE approved by the FDA?

MICROMATE received FDA 510(k) clearance on 2021-06-22, under approval number K203720.

What company makes MICROMATE?

MICROMATE is manufactured by Isys Medizintechnik GmbH.

What is the FDA product code for MICROMATE?

The FDA product code for MICROMATE is JAK.

Other Devices by Isys Medizintechnik GmbH

K230130Micromate™ Navi+

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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.

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