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FDA 510(k)

TD-4183 Blood Glucose Monitoring System

K-Number: K190579 · 2019-06-04

ApplicantTaidoc Technology Corporation
Decision Date2019-06-04
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TD-4183 Blood Glucose Monitoring System is a medical device manufactured by Taidoc Technology Corporation. It received FDA 510(k) clearance on 2019-06-04 under approval number K190579. 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 TD-4183 Blood Glucose Monitoring System?

TD-4183 Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2019-06-04. It is manufactured by Taidoc Technology Corporation. The 510(k) number is K190579.

When was TD-4183 Blood Glucose Monitoring System approved by the FDA?

TD-4183 Blood Glucose Monitoring System received FDA 510(k) clearance on 2019-06-04, under approval number K190579.

What company makes TD-4183 Blood Glucose Monitoring System?

TD-4183 Blood Glucose Monitoring System is manufactured by Taidoc Technology Corporation.

What is the FDA product code for TD-4183 Blood Glucose Monitoring System?

The FDA product code for TD-4183 Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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Related PubMed Literature

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Other Devices by Taidoc Technology Corporation

K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems K152680TD-1035 Thermometer K151024Finger Type Pulse Oximeter K142664URight Hemoglobin A1c system, FORA A1c System K162382Smart Dongle Blood Glucose Monitoring System K180863FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator

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Related Devices (Code: NBW)

K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring SystemApex BioTechnology Corp. K160742NoCoding1 Plus Blood Glucose Monitoring SystemI-Sens, Inc. K161834One Drop Blood Glucose Monitoring SystemAgamatrix, Inc. K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring SystemsTaidoc Technology Corporation K160365BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring SystemInfopia 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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