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FDA 510(k)

BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951

K-Number: K101307 · 2011-08-09

ApplicantAndon Medical Co., Ltd.
Decision Date2011-08-09
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951 is the device name listed in this FDA 510(k) record. The listed applicant is Andon Medical Co., Ltd.. It received FDA 510(k) clearance on 2011-08-09 under 510(k) number K101307. 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 BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951?

BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951 is a medical device that received FDA 510(k) clearance on 2011-08-09. The listed applicant is Andon Medical Co., Ltd.. The 510(k) number is K101307.

When did BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951 receive FDA 510(k) clearance?

BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951 received FDA 510(k) clearance on 2011-08-09, under 510(k) number K101307.

Who is the listed applicant for BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951?

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

What is the FDA product code for BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951?

The FDA product code for BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951 is NBW. This falls under the OB/GYN category.

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Other records listing Andon Medical 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.

K123935IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEMK120813BLOOD GLUCOSE MONITORING SYSTEMK110017AG-608N BLOOD GLUCOSE MONITORING SYSTEMK112738ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWAREK102678ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMSK093755AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM

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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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