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FDA 510(k)

EasyStat 300

K-Number: K211559 · 2023-01-27

ApplicantMedica Corporation
Decision Date2023-01-27
Product CodeCHL
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 2023-01-27 under 510(k) number K211559. The device is classified under product code CHL. 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 2023-01-27. The listed applicant is Medica Corporation. The 510(k) number is K211559.

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

EasyStat 300 received FDA 510(k) clearance on 2023-01-27, under 510(k) number K211559.

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 CHL.

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 300K220396EasyStat 300K152327EasyLyte Na/K/Cl/Ca Analyzer

Related Devices (Code: CHL)

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.

K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals ApsK244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K240998ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230285i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K221900Stat Profile Prime Plus Analyzer SystemNova Biomedical CorporationK223857i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.

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.

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