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FDA 510(k)

YSI MODEL 2300 STAT PLUS

K-Number: K913806 · 1991-10-02

ApplicantYsis, Inc.
Decision Date1991-10-02
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

YSI MODEL 2300 STAT PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Ysis, Inc.. It received FDA 510(k) clearance on 1991-10-02 under 510(k) number K913806. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the YSI MODEL 2300 STAT PLUS?

YSI MODEL 2300 STAT PLUS is a medical device that received FDA 510(k) clearance on 1991-10-02. The listed applicant is Ysis, Inc.. The 510(k) number is K913806.

When did YSI MODEL 2300 STAT PLUS receive FDA 510(k) clearance?

YSI MODEL 2300 STAT PLUS received FDA 510(k) clearance on 1991-10-02, under 510(k) number K913806.

Who is the listed applicant for YSI MODEL 2300 STAT PLUS?

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

What is the FDA product code for YSI MODEL 2300 STAT PLUS?

The FDA product code for YSI MODEL 2300 STAT PLUS is CGA.

Related Clinical Trials

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Other records listing Ysis, Inc. 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.

K921561YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBES

Related Devices (Code: CGA)

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.

K252488ABL90 FLEX PLUS SystemRadiometer Medicals ApsK210933YSI 2900C Biochemistry AnalyzerYsi, Inc.K220328EasyStat 300Medica CorporationK223179Cholestech LDX ™ SystemAlere San Diego, Inc.K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K223710i-STAT CG8+ 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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