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TeleRPM Gen2 Blood Glucose Monitoring System

Page Type
Cleared 510(K)
510(k) Number
K243060
510(k) Type
Traditional
Applicant
Guangdong Transtek Medical Electronics Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
1/30/2025
Days to Decision
125 days
Submission Type
Summary

TeleRPM Gen2 Blood Glucose Monitoring System

Page Type
Cleared 510(K)
510(k) Number
K243060
510(k) Type
Traditional
Applicant
Guangdong Transtek Medical Electronics Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
1/30/2025
Days to Decision
125 days
Submission Type
Summary