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FDA 510(k) Application Details - K200862
Device Classification Name
Stethoscope, Electronic
More FDA Info for this Device
510(K) Number
K200862
Device Name
Stethoscope, Electronic
Applicant
Sonavi Labs, Inc.
1100 Wicomico St., Suite 600
Baltimore, MD 21230 US
Other 510(k) Applications for this Company
Contact
Ian McLane
Other 510(k) Applications for this Contact
Regulation Number
870.1875
More FDA Info for this Regulation Number
Classification Product Code
DQD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/01/2020
Decision Date
09/14/2020
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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