FDA 510(k)

MDT2 BLE Self-Monitoring Blood Glucose System

K-Number: K190189 · 2019-11-01

Decision Date2019-11-01

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

MDT2 BLE Self-Monitoring Blood Glucose System is the device name listed in this FDA 510(k) record. The listed applicant is Eps Bio Technology Corp.. It received FDA 510(k) clearance on 2019-11-01 under 510(k) number K190189. 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 MDT2 BLE Self-Monitoring Blood Glucose System?

MDT2 BLE Self-Monitoring Blood Glucose System is a medical device that received FDA 510(k) clearance on 2019-11-01. The listed applicant is Eps Bio Technology Corp.. The 510(k) number is K190189.

When did MDT2 BLE Self-Monitoring Blood Glucose System receive FDA 510(k) clearance?

MDT2 BLE Self-Monitoring Blood Glucose System received FDA 510(k) clearance on 2019-11-01, under 510(k) number K190189.

Who is the listed applicant for MDT2 BLE Self-Monitoring Blood Glucose System?

The FDA 510(k) record lists Eps Bio Technology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MDT2 BLE Self-Monitoring Blood Glucose System?

The FDA product code for MDT2 BLE Self-Monitoring Blood Glucose 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.

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Other records listing Eps Bio Technology Corp. as applicant

K201258EASYMAX Tag Self-Monitoring Blood Glucose System K182057EasyMax BT Self-Monitoring Blood Glucose System

Related Devices (Code: NBW)

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.K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc.

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.