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FDA 510(k)

Joimax Intracs System

K-Number: K192663 · 2020-07-30

ApplicantJoimax GmbH
Decision Date2020-07-30
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Joimax Intracs System is the device name listed in this FDA 510(k) record. The listed applicant is Joimax GmbH. It received FDA 510(k) clearance on 2020-07-30 under 510(k) number K192663. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Joimax Intracs System?

Joimax Intracs System is a medical device that received FDA 510(k) clearance on 2020-07-30. The listed applicant is Joimax GmbH. The 510(k) number is K192663.

When did Joimax Intracs System receive FDA 510(k) clearance?

Joimax Intracs System received FDA 510(k) clearance on 2020-07-30, under 510(k) number K192663.

Who is the listed applicant for Joimax Intracs System?

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

What is the FDA product code for Joimax Intracs System?

The FDA product code for Joimax Intracs System is OLO.

Other records listing Joimax 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.

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Related Devices (Code: OLO)

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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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