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GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K121433
510(k) Type
Traditional
Applicant
HMD BIOMEDICAL, INC.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
2/14/2013
Days to Decision
276 days
Submission Type
Summary

GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K121433
510(k) Type
Traditional
Applicant
HMD BIOMEDICAL, INC.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
2/14/2013
Days to Decision
276 days
Submission Type
Summary