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 a medical device manufactured by ImpediMed Limited. It received FDA 510(k) clearance on 2023-05-04 under approval 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. It is manufactured by ImpediMed Limited. The 510(k) number is K230530.
When was SOZO Pro approved by the FDA?
SOZO Pro received FDA 510(k) clearance on 2023-05-04, under approval number K230530.
What company makes SOZO Pro?
SOZO Pro is manufactured by ImpediMed Limited.
What is the FDA product code for SOZO Pro?
The FDA product code for SOZO Pro is OBH.
Other Devices by ImpediMed Limited
Related Devices (Code: OBH)
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.