FDA 510(k)

IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM

K-Number: K123935 · 2013-04-12

Decision Date2013-04-12

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

IHEALTH BG5/BG5L WIRELESS SMART 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 2013-04-12 under 510(k) number K123935. 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 IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM?

IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2013-04-12. The listed applicant is Andon Medical Co., Ltd.. The 510(k) number is K123935.

When did IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM receive FDA 510(k) clearance?

IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2013-04-12, under 510(k) number K123935.

Who is the listed applicant for IHEALTH BG5/BG5L WIRELESS SMART 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 IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM?

The FDA product code for IHEALTH BG5/BG5L WIRELESS SMART 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

K120813BLOOD GLUCOSE MONITORING SYSTEM K110017AG-608N BLOOD GLUCOSE MONITORING SYSTEM K112738ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE K102678ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS K101307BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951 K093755AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM

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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.