Oncospace
K-Number: K242748 · 2025-04-11
ApplicantOncospace, Inc.
Decision Date2025-04-11
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Oncospace is a medical device manufactured by Oncospace, Inc.. It received FDA 510(k) clearance on 2025-04-11 under approval number K242748. 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 2025-04-11. It is manufactured by Oncospace, Inc.. The 510(k) number is K242748.
When was Oncospace approved by the FDA?
Oncospace received FDA 510(k) clearance on 2025-04-11, under approval number K242748.
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.
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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.