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FDA 510(k) Application Details - K220466
Device Classification Name
Stethoscope, Electronic
More FDA Info for this Device
510(K) Number
K220466
Device Name
Stethoscope, Electronic
Applicant
Sound Land Corp.
No.32, Keji 1st Rd., Guishan Dist.
Taoyuan 33383 TW
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Contact
Chi-Hsun Hung
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
02/17/2022
Decision Date
11/03/2022
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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