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FDA 510(k)

Superflow Prime Treatment System (ASP-1M)

K-Number: K242286 · 2024-11-08

ApplicantGuangzhou Aimira Innovation Technology Co, Ltd.
Decision Date2024-11-08
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Superflow Prime Treatment System (ASP-1M) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Aimira Innovation Technology Co, Ltd.. It received FDA 510(k) clearance on 2024-11-08 under 510(k) number K242286. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Superflow Prime Treatment System (ASP-1M)?

Superflow Prime Treatment System (ASP-1M) is a medical device that received FDA 510(k) clearance on 2024-11-08. The listed applicant is Guangzhou Aimira Innovation Technology Co, Ltd.. The 510(k) number is K242286.

When did Superflow Prime Treatment System (ASP-1M) receive FDA 510(k) clearance?

Superflow Prime Treatment System (ASP-1M) received FDA 510(k) clearance on 2024-11-08, under 510(k) number K242286.

Who is the listed applicant for Superflow Prime Treatment System (ASP-1M)?

The FDA 510(k) record lists Guangzhou Aimira Innovation Technology Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Superflow Prime Treatment System (ASP-1M)?

The FDA product code for Superflow Prime Treatment System (ASP-1M) is GEI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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