DeGen Impulse AM System
K-Number: K223418 · 2023-03-17
ApplicantDegen Medical
Decision Date2023-03-17
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
DeGen Impulse AM System is a medical device manufactured by Degen Medical. It received FDA 510(k) clearance on 2023-03-17 under approval number K223418. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DeGen Impulse AM System?
DeGen Impulse AM System is a medical device that received FDA 510(k) clearance on 2023-03-17. It is manufactured by Degen Medical. The 510(k) number is K223418.
When was DeGen Impulse AM System approved by the FDA?
DeGen Impulse AM System received FDA 510(k) clearance on 2023-03-17, under approval number K223418.
What company makes DeGen Impulse AM System?
DeGen Impulse AM System is manufactured by Degen Medical.
What is the FDA product code for DeGen Impulse AM System?
The FDA product code for DeGen Impulse AM System is MAX.
Related Clinical Trials
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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.