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FDA 510(k) Application Details - K241728
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K241728
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
Murata Vios, Inc.
700 Commerce Drive, #190
Woodbury, MN 55125 US
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Contact
Amit Patel
Other 510(k) Applications for this Contact
Regulation Number
870.1130
More FDA Info for this Regulation Number
Classification Product Code
DXN
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More FDA Info for this Product Code
Date Received
06/14/2024
Decision Date
01/23/2025
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K241728
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