ProSeal Closed System drug Transfer Device (CSTD)
K-Number: K192075 · 2020-08-07
ApplicantEpic Medical Pte. , Ltd.
Decision Date2020-08-07
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
ProSeal Closed System drug Transfer Device (CSTD) is a medical device manufactured by Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2020-08-07 under approval number K192075. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ProSeal Closed System drug Transfer Device (CSTD)?
ProSeal Closed System drug Transfer Device (CSTD) is a medical device that received FDA 510(k) clearance on 2020-08-07. It is manufactured by Epic Medical Pte. , Ltd.. The 510(k) number is K192075.
When was ProSeal Closed System drug Transfer Device (CSTD) approved by the FDA?
ProSeal Closed System drug Transfer Device (CSTD) received FDA 510(k) clearance on 2020-08-07, under approval number K192075.
What company makes ProSeal Closed System drug Transfer Device (CSTD)?
ProSeal Closed System drug Transfer Device (CSTD) is manufactured by Epic Medical Pte. , Ltd..
What is the FDA product code for ProSeal Closed System drug Transfer Device (CSTD)?
The FDA product code for ProSeal Closed System drug Transfer Device (CSTD) is ONB.
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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.