SOZO
K-Number: K180126 · 2018-04-16
ApplicantImpediMed Limited
Decision Date2018-04-16
Product CodeOBH
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
SOZO is a medical device manufactured by ImpediMed Limited. It received FDA 510(k) clearance on 2018-04-16 under approval 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. It is manufactured by ImpediMed Limited. The 510(k) number is K180126.
When was SOZO approved by the FDA?
SOZO received FDA 510(k) clearance on 2018-04-16, under approval number K180126.
What company makes SOZO?
SOZO is manufactured by ImpediMed Limited.
What is the FDA product code for SOZO?
The FDA product code for SOZO 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.