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FDA 510(k)

EASYGLUCO IGM-0002 G2

K-Number: K043512 · 2005-04-08

ApplicantAmerican Healthcare, Inc.
Decision Date2005-04-08
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASYGLUCO IGM-0002 G2 is the device name listed in this FDA 510(k) record. The listed applicant is American Healthcare, Inc.. It received FDA 510(k) clearance on 2005-04-08 under 510(k) number K043512. 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 EASYGLUCO IGM-0002 G2?

EASYGLUCO IGM-0002 G2 is a medical device that received FDA 510(k) clearance on 2005-04-08. The listed applicant is American Healthcare, Inc.. The 510(k) number is K043512.

When did EASYGLUCO IGM-0002 G2 receive FDA 510(k) clearance?

EASYGLUCO IGM-0002 G2 received FDA 510(k) clearance on 2005-04-08, under 510(k) number K043512.

Who is the listed applicant for EASYGLUCO IGM-0002 G2?

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

What is the FDA product code for EASYGLUCO IGM-0002 G2?

The FDA product code for EASYGLUCO IGM-0002 G2 is CGA.

Related Clinical Trials

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Other records listing American Healthcare, 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.

K043543BLOOD GLUCOSE MONITORING SYSTEMK031501EASYGLUCO, MODEL IGM0002

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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