FDA 510(k)

ACU007S

K-Number: K092522 · 2009-11-20

Decision Date2009-11-20

Product CodeKXK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ACU007S is the device name listed in this FDA 510(k) record. The listed applicant is Oncology Systems, Inc.. It received FDA 510(k) clearance on 2009-11-20 under 510(k) number K092522. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACU007S?

ACU007S is a medical device that received FDA 510(k) clearance on 2009-11-20. The listed applicant is Oncology Systems, Inc.. The 510(k) number is K092522.

When did ACU007S receive FDA 510(k) clearance?

ACU007S received FDA 510(k) clearance on 2009-11-20, under 510(k) number K092522.

Who is the listed applicant for ACU007S?

The FDA 510(k) record lists Oncology Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACU007S?

The FDA product code for ACU007S is KXK.

Other records listing Oncology Systems, 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.

K123357ONQ RTS K051753ACCU-SOURCE K871810PLAN-32 SOFTWARE

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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.