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FDA 510(k)

AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K093262 · 2010-07-13

ApplicantAndon Medical Co., Ltd.
Decision Date2010-07-13
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM 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 2010-07-13 under 510(k) number K093262. 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 AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM?

AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2010-07-13. The listed applicant is Andon Medical Co., Ltd.. The 510(k) number is K093262.

When did AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM receive FDA 510(k) clearance?

AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2010-07-13, under 510(k) number K093262.

Who is the listed applicant for AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM?

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 AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM 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 SYSTEMSK101307BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951

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Related Devices (Code: NBW)

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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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