MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)
K-Number: K253224 · 2026-01-28
Device Summary
Frequently Asked Questions
What is the MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)?
MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) is a medical device that received FDA 510(k) clearance on 2026-01-28. The listed applicant is ImpediMed Limited. The 510(k) number is K253224.
When did MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) receive FDA 510(k) clearance?
MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) received FDA 510(k) clearance on 2026-01-28, under 510(k) number K253224.
Who is the listed applicant for MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)?
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 MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)?
The FDA product code for MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) 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.
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.