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FDA 510(k) Application Details - K212709
Device Classification Name
Stethoscope, Electronic
More FDA Info for this Device
510(K) Number
K212709
Device Name
Stethoscope, Electronic
Applicant
Sanolla Ltd.
19 Ha'Mesilla Street
Nesher 3688519 IL
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Contact
Doron Adler
Other 510(k) Applications for this Contact
Regulation Number
870.1875
More FDA Info for this Regulation Number
Classification Product Code
DQD
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More FDA Info for this Product Code
Date Received
08/26/2021
Decision Date
03/15/2022
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
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