FDA 510(k)

POPS! one Blood Glucose Monitoring System

Numéro K : K181588 · 2018-11-30

Date de décision2018-11-30

Code produitNBW

Comité consultatifCH

DécisionSubstantially Equivalent

Résumé du dispositif

POPS! one Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Taidoc Technology Corporation. It received FDA 510(k) clearance on 2018-11-30 under 510(k) 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.

Questions fréquentes

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. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K181588.

When did POPS! one Blood Glucose Monitoring System receive FDA 510(k) clearance?

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

Who is the listed applicant for POPS! one Blood Glucose Monitoring System?

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

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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Source officielle

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