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FDA 510(k)

GLUCODR AUTO SYSTEM

K-Number: K083628 · 2009-05-01

ApplicantAll Medicus Co., Ltd.
Decision Date2009-05-01
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCODR AUTO SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is All Medicus Co., Ltd.. It received FDA 510(k) clearance on 2009-05-01 under 510(k) number K083628. 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 GLUCODR AUTO SYSTEM?

GLUCODR AUTO SYSTEM is a medical device that received FDA 510(k) clearance on 2009-05-01. The listed applicant is All Medicus Co., Ltd.. The 510(k) number is K083628.

When did GLUCODR AUTO SYSTEM receive FDA 510(k) clearance?

GLUCODR AUTO SYSTEM received FDA 510(k) clearance on 2009-05-01, under 510(k) number K083628.

Who is the listed applicant for GLUCODR AUTO SYSTEM?

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

What is the FDA product code for GLUCODR AUTO SYSTEM?

The FDA product code for GLUCODR AUTO SYSTEM is NBW. This falls under the OB/GYN category.

Related Clinical Trials

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Other records listing All Medicus 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.

K170241GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring SystemK130657LINKDR 2.0 DIABETES MANAGEMENT SOFTWAREK082328GLUCODR PLUS SYSTEM, MODEL AGM-3000K050985GLUCODR SUPERSENSOR SYSTEM

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.

K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes CareK262116TRUE 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 CorporationK240640Sejoy 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.

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