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FDA 510(k)

POPS! one Blood Glucose Monitoring System

K-Number: K181588 · 2018-11-30

ApplicantTaidoc Technology Corporation
Decision Date2018-11-30
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

POPS! one Blood Glucose Monitoring System is a medical device manufactured by Taidoc Technology Corporation. It received FDA 510(k) clearance on 2018-11-30 under approval number K181588. 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 POPS! one Blood Glucose Monitoring System?

POPS! one Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2018-11-30. It is manufactured by Taidoc Technology Corporation. The 510(k) number is K181588.

When was POPS! one Blood Glucose Monitoring System approved by the FDA?

POPS! one Blood Glucose Monitoring System received FDA 510(k) clearance on 2018-11-30, under approval number K181588.

What company makes POPS! one Blood Glucose Monitoring System?

POPS! one Blood Glucose Monitoring System is manufactured by Taidoc Technology Corporation.

What is the FDA product code for POPS! one Blood Glucose Monitoring System?

The FDA product code for POPS! one 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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