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FDA 510(k)

GLUCODR PLUS SYSTEM, MODEL AGM-3000

K-Number: K082328 · 2009-02-27

ApplicantAll Medicus Co., Ltd.
Decision Date2009-02-27
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCODR PLUS SYSTEM, MODEL AGM-3000 is the device name listed in this FDA 510(k) record. The listed applicant is All Medicus Co., Ltd.. It received FDA 510(k) clearance on 2009-02-27 under 510(k) number K082328. 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 GLUCODR PLUS SYSTEM, MODEL AGM-3000?

GLUCODR PLUS SYSTEM, MODEL AGM-3000 is a medical device that received FDA 510(k) clearance on 2009-02-27. The listed applicant is All Medicus Co., Ltd.. The 510(k) number is K082328.

When did GLUCODR PLUS SYSTEM, MODEL AGM-3000 receive FDA 510(k) clearance?

GLUCODR PLUS SYSTEM, MODEL AGM-3000 received FDA 510(k) clearance on 2009-02-27, under 510(k) number K082328.

Who is the listed applicant for GLUCODR PLUS SYSTEM, MODEL AGM-3000?

The FDA 510(k) record lists All Medicus Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLUCODR PLUS SYSTEM, MODEL AGM-3000?

The FDA product code for GLUCODR PLUS SYSTEM, MODEL AGM-3000 is NBW. This falls under the OB/GYN category.

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Other records listing All Medicus Co., Ltd. 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.

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Related Devices (Code: NBW)

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Official Source

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