FDA 510(k) Application Details - K220466

Device Classification Name Stethoscope, Electronic

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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
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Regulation Number 870.1875

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Classification Product Code DQD
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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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