ACUTRON
K-Number: K211000 · 2022-06-09
Device Summary
Frequently Asked Questions
What is the ACUTRON?
ACUTRON is a medical device that received FDA 510(k) clearance on 2022-06-09. The listed applicant is Ilooda Co,., Ltd.. The 510(k) number is K211000.
When did ACUTRON receive FDA 510(k) clearance?
ACUTRON received FDA 510(k) clearance on 2022-06-09, under 510(k) number K211000.
Who is the listed applicant for ACUTRON?
The FDA 510(k) record lists Ilooda Co,., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ACUTRON?
The FDA product code for ACUTRON is GEI.
Other records listing Ilooda Co,., Ltd. 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: GEI)
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.