FDA 510(k)

EasyStat 300

K-Number: K220396 · 2023-09-26

Decision Date2023-09-26

Product CodeCEM

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

EasyStat 300 is the device name listed in this FDA 510(k) record. The listed applicant is Medica Corporation. It received FDA 510(k) clearance on 2023-09-26 under 510(k) 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. The listed applicant is Medica Corporation. The 510(k) number is K220396.

When did EasyStat 300 receive FDA 510(k) clearance?

EasyStat 300 received FDA 510(k) clearance on 2023-09-26, under 510(k) number K220396.

Who is the listed applicant for EasyStat 300?

The FDA 510(k) record lists Medica Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EasyStat 300?

The FDA product code for EasyStat 300 is CEM.

Other records listing Medica Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220328EasyStat 300 K211559EasyStat 300 K152327EasyLyte Na/K/Cl/Ca Analyzer

Related Devices (Code: CEM)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.