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RM STAR EX with RMS Needle

Page Type
Cleared 510(K)
510(k) Number
K243097
510(k) Type
Traditional
Applicant
BOMTECH ELECTRONICS CO., LTD.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
12/26/2024
Days to Decision
87 days
Submission Type
Summary

RM STAR EX with RMS Needle

Page Type
Cleared 510(K)
510(k) Number
K243097
510(k) Type
Traditional
Applicant
BOMTECH ELECTRONICS CO., LTD.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
12/26/2024
Days to Decision
87 days
Submission Type
Summary