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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Isys Medizintechnik GmbH. It received FDA 510(k) clearance on 2023-10-10 under 510(k) 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. The listed applicant is Isys Medizintechnik GmbH. The 510(k) number is K230130.

When did Micromate™ Navi+ receive FDA 510(k) clearance?

Micromate™ Navi+ received FDA 510(k) clearance on 2023-10-10, under 510(k) number K230130.

Who is the listed applicant for Micromate™ Navi+?

The FDA 510(k) record lists Isys Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Micromate™ Navi+?

The FDA product code for Micromate™ Navi+ is JAK.

Other records listing Isys Medizintechnik GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203720MICROMATE

Related Devices (Code: JAK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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