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FDA 510(k)

Miha Bodytec II

K-Number: K182519 · 2019-06-07

Decision Date2019-06-07
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Miha Bodytec II is the device name listed in this FDA 510(k) record. The listed applicant is Miha Bodytec GmbH. It received FDA 510(k) clearance on 2019-06-07 under 510(k) number K182519. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Miha Bodytec II?

Miha Bodytec II is a medical device that received FDA 510(k) clearance on 2019-06-07. The listed applicant is Miha Bodytec GmbH. The 510(k) number is K182519.

When did Miha Bodytec II receive FDA 510(k) clearance?

Miha Bodytec II received FDA 510(k) clearance on 2019-06-07, under 510(k) number K182519.

Who is the listed applicant for Miha Bodytec II?

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

What is the FDA product code for Miha Bodytec II?

The FDA product code for Miha Bodytec II is NGX.

Other records listing Miha Bodytec 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.

Related Devices (Code: NGX)

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.

Official Source

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