DolorClast Radial
K-Number: K220538 · 2022-07-11
ApplicantE.M.S Electro Medical Systems S.A
Decision Date2022-07-11
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
DolorClast Radial is a medical device manufactured by E.M.S Electro Medical Systems S.A. It received FDA 510(k) clearance on 2022-07-11 under approval number K220538. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DolorClast Radial?
DolorClast Radial is a medical device that received FDA 510(k) clearance on 2022-07-11. It is manufactured by E.M.S Electro Medical Systems S.A. The 510(k) number is K220538.
When was DolorClast Radial approved by the FDA?
DolorClast Radial received FDA 510(k) clearance on 2022-07-11, under approval number K220538.
What company makes DolorClast Radial?
DolorClast Radial is manufactured by E.M.S Electro Medical Systems S.A.
What is the FDA product code for DolorClast Radial?
The FDA product code for DolorClast Radial is ISA.
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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.