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FDA 510(k)

SOZO Pro

K-Number: K230530 · 2023-05-04

ApplicantImpediMed Limited
Decision Date2023-05-04
Product CodeOBH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOZO Pro is the device name listed in this FDA 510(k) record. The listed applicant is ImpediMed Limited. It received FDA 510(k) clearance on 2023-05-04 under 510(k) number K230530. 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 Pro?

SOZO Pro is a medical device that received FDA 510(k) clearance on 2023-05-04. The listed applicant is ImpediMed Limited. The 510(k) number is K230530.

When did SOZO Pro receive FDA 510(k) clearance?

SOZO Pro received FDA 510(k) clearance on 2023-05-04, under 510(k) number K230530.

Who is the listed applicant for SOZO Pro?

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 Pro?

The FDA product code for SOZO Pro 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.

K253224MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)K232089SOZO ProK230531SOZO ProK203473SOZOK193410SOZO Body Fluid AnalyzerK190529SOZO

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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.

K253224MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)ImpediMed LimitedK220557MoistureMeterD Compact, LymphScannerDelfin Technologies, Ltd.K180126SOZOImpediMed LimitedK172122SOZOImpediMed Limited

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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