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FDA 510(k)

SOZO

K-Number: K180126 · 2018-04-16

Decision Date2018-04-16
Product CodeOBH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOZO is the device name listed in this FDA 510(k) record. The listed applicant is ImpediMed Limited. It received FDA 510(k) clearance on 2018-04-16 under 510(k) number K180126. The device is classified under product code OBH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOZO?

SOZO is a medical device that received FDA 510(k) clearance on 2018-04-16. The listed applicant is ImpediMed Limited. The 510(k) number is K180126.

When did SOZO receive FDA 510(k) clearance?

SOZO received FDA 510(k) clearance on 2018-04-16, under 510(k) number K180126.

Who is the listed applicant for SOZO?

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

What is the FDA product code for SOZO?

The FDA product code for SOZO is OBH.

Other records listing ImpediMed Limited 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.

View all 10 devices →

Related Devices (Code: OBH)

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.