FDA 510(k)

Oncospace

K-Number: K202284 · 2021-03-12

Decision Date2021-03-12

Product CodeMUJ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Oncospace is a medical device manufactured by Oncospace, Inc.. It received FDA 510(k) clearance on 2021-03-12 under approval number K202284. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Oncospace?

Oncospace is a medical device that received FDA 510(k) clearance on 2021-03-12. It is manufactured by Oncospace, Inc.. The 510(k) number is K202284.

When was Oncospace approved by the FDA?

Oncospace received FDA 510(k) clearance on 2021-03-12, under approval number K202284.

What company makes Oncospace?

Oncospace is manufactured by Oncospace, Inc..

What is the FDA product code for Oncospace?

The FDA product code for Oncospace is MUJ.

Other Devices by Oncospace, Inc.

K222803Oncospace K242748Oncospace

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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.