FDA 510(k)

AG-608N BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K110017 · 2012-01-18

Decision Date2012-01-18

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

AG-608N 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 2012-01-18 under 510(k) number K110017. 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-608N BLOOD GLUCOSE MONITORING SYSTEM?

AG-608N BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2012-01-18. The listed applicant is Andon Medical Co., Ltd.. The 510(k) number is K110017.

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

AG-608N BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2012-01-18, under 510(k) number K110017.

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

The FDA product code for AG-608N BLOOD GLUCOSE MONITORING SYSTEM is NBW. This falls under the OB/GYN category.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Andon Medical Co., Ltd. as applicant

K123935IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM K120813BLOOD 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

View all 9 devices →

Related Devices (Code: NBW)

K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care K262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc.K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring SystemACON Laboratories, Inc.K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd.K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation K240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd.

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.