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FDA 510(k)

TeleRPM Gen2 Blood Glucose Monitoring System

K-Number: K243060 · 2025-01-30

ApplicantGuangdong Transtek Medical Electronics Co., Ltd.
Decision Date2025-01-30
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Guangdong Transtek Medical Electronics Co., Ltd. as applicant

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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Related Devices (Code: NBW)

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.

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.K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime CorporationK240640Sejoy 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.K222126VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring SystemVivachek Biotech (Hangzhou) 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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