EasyStat 300
K-Number: K220396 · 2023-09-26
ApplicantMedica Corporation
Decision Date2023-09-26
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
EasyStat 300 is a medical device manufactured by Medica Corporation. It received FDA 510(k) clearance on 2023-09-26 under approval number K220396. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EasyStat 300?
EasyStat 300 is a medical device that received FDA 510(k) clearance on 2023-09-26. It is manufactured by Medica Corporation. The 510(k) number is K220396.
When was EasyStat 300 approved by the FDA?
EasyStat 300 received FDA 510(k) clearance on 2023-09-26, under approval number K220396.
What company makes EasyStat 300?
EasyStat 300 is manufactured by Medica Corporation.
What is the FDA product code for EasyStat 300?
The FDA product code for EasyStat 300 is CEM.
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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.