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FDA 510(k)

EASYGLUCO, MODEL IGM-0002 G2

K-Number: K061431 · 2007-01-12

ApplicantU. S. Diagnostics, Inc.
Decision Date2007-01-12
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASYGLUCO, MODEL IGM-0002 G2 is the device name listed in this FDA 510(k) record. The listed applicant is U. S. Diagnostics, Inc.. It received FDA 510(k) clearance on 2007-01-12 under 510(k) number K061431. 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, MODEL IGM-0002 G2?

EASYGLUCO, MODEL IGM-0002 G2 is a medical device that received FDA 510(k) clearance on 2007-01-12. The listed applicant is U. S. Diagnostics, Inc.. The 510(k) number is K061431.

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

EASYGLUCO, MODEL IGM-0002 G2 received FDA 510(k) clearance on 2007-01-12, under 510(k) number K061431.

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

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

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

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

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Other records listing U. S. Diagnostics, Inc. as applicant

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Related Devices (Code: CGA)

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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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