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FDA 510(k)

AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System

K-Number: K153561 · 2017-02-16

ApplicantAndon Health Co, Ltd.
Decision Date2017-02-16
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2017-02-16 under 510(k) number K153561. 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-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System?

AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2017-02-16. The listed applicant is Andon Health Co, Ltd.. The 510(k) number is K153561.

When did AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System receive FDA 510(k) clearance?

AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System received FDA 510(k) clearance on 2017-02-16, under 510(k) number K153561.

Who is the listed applicant for AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System?

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

What is the FDA product code for AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System?

The FDA product code for AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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Related Devices (Code: NBW)

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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Official Source

View on FDA Database →

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