FDA 510(k)

TeleRPM Gen2 Blood Glucose Monitoring System

Numéro K : K243060 · 2025-01-30

DemandeurGuangdong Transtek Medical Electronics Co., Ltd.

Date de décision2025-01-30

Code produitNBW

Comité consultatifCH

DécisionSubstantially Equivalent

Résumé du dispositif

TeleRPM Gen2 Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Transtek Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-01-30 under 510(k) number K243060. 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 TeleRPM Gen2 Blood Glucose Monitoring System?

TeleRPM Gen2 Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2025-01-30. The listed applicant is Guangdong Transtek Medical Electronics Co., Ltd.. The 510(k) number is K243060.

When did TeleRPM Gen2 Blood Glucose Monitoring System receive FDA 510(k) clearance?

TeleRPM Gen2 Blood Glucose Monitoring System received FDA 510(k) clearance on 2025-01-30, under 510(k) number K243060.

Who is the listed applicant for TeleRPM Gen2 Blood Glucose Monitoring System?

The FDA 510(k) record lists Guangdong Transtek Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TeleRPM Gen2 Blood Glucose Monitoring System?

The FDA product code for TeleRPM Gen2 Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

Essais cliniques associés

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Source officielle

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