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FDA 510(k) Application Details - K170874
Device Classification Name
Stethoscope, Electronic
More FDA Info for this Device
510(K) Number
K170874
Device Name
Stethoscope, Electronic
Applicant
Eko Devices, Inc.
2600 10th St, Suite 260
Berkeley, CA 94710 US
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Contact
Connor Landgraf
Other 510(k) Applications for this Contact
Regulation Number
870.1875
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Classification Product Code
DQD
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More FDA Info for this Product Code
Date Received
03/24/2017
Decision Date
05/19/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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