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FDA 510(k)

EASYGLUCO, MODEL IGM0002

K-Number: K031501 · 2003-10-16

ApplicantAmerican Healthcare, Inc.
Decision Date2003-10-16
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASYGLUCO, MODEL IGM0002 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 2003-10-16 under 510(k) number K031501. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASYGLUCO, MODEL IGM0002?

EASYGLUCO, MODEL IGM0002 is a medical device that received FDA 510(k) clearance on 2003-10-16. The listed applicant is American Healthcare, Inc.. The 510(k) number is K031501.

When did EASYGLUCO, MODEL IGM0002 receive FDA 510(k) clearance?

EASYGLUCO, MODEL IGM0002 received FDA 510(k) clearance on 2003-10-16, under 510(k) number K031501.

Who is the listed applicant for EASYGLUCO, MODEL IGM0002?

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, MODEL IGM0002?

The FDA product code for EASYGLUCO, MODEL IGM0002 is NBW. This falls under the OB/GYN category.

Related Clinical Trials

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.

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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.

K043512EASYGLUCO IGM-0002 G2K043543BLOOD GLUCOSE MONITORING SYSTEM

Related Devices (Code: NBW)

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.

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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.

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