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510(k) K243060

TeleRPM Gen2 Blood Glucose Monitoring System by Guangdong Transtek Medical Electronics Co., Ltd. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2025
Date Received
September 27, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Blood Glucose, Over The Counter
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

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  • K220676 — Blood Pressure Monitor (August 29, 2022)
  • K202891 — Blood Pressure Monitor (March 9, 2021)

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