6430 MyLabX75, 6430 MyLab XPro75
K-Number: K212021 · 2021-09-16
Device Summary
Frequently Asked Questions
What is the 6430 MyLabX75, 6430 MyLab XPro75?
6430 MyLabX75, 6430 MyLab XPro75 is a medical device that received FDA 510(k) clearance on 2021-09-16. The listed applicant is Esaote, S.p.A.. The 510(k) number is K212021.
When did 6430 MyLabX75, 6430 MyLab XPro75 receive FDA 510(k) clearance?
6430 MyLabX75, 6430 MyLab XPro75 received FDA 510(k) clearance on 2021-09-16, under 510(k) number K212021.
Who is the listed applicant for 6430 MyLabX75, 6430 MyLab XPro75?
The FDA 510(k) record lists Esaote, S.p.A. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 6430 MyLabX75, 6430 MyLab XPro75?
The FDA product code for 6430 MyLabX75, 6430 MyLab XPro75 is IYN.
Other records listing Esaote, S.p.A. 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: IYN)
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.