Root ZX3
K-Number: K213477 · 2022-08-03
Device Summary
Frequently Asked Questions
What is the Root ZX3?
Root ZX3 is a medical device that received FDA 510(k) clearance on 2022-08-03. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K213477.
When did Root ZX3 receive FDA 510(k) clearance?
Root ZX3 received FDA 510(k) clearance on 2022-08-03, under 510(k) number K213477.
Who is the listed applicant for Root ZX3?
The FDA 510(k) record lists J. Morita USA, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Root ZX3?
The FDA product code for Root ZX3 is EKZ.
Related Clinical Trials
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.
Other records listing J. Morita USA, Inc. 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.
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.