FDA 510(k) Application Details - K222871

Device Classification Name Stethoscope, Electronic

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510(K) Number K222871
Device Name Stethoscope, Electronic
Applicant Sparrow Acoustics Inc.
2416 Natura Dr
Lucasville B4B0X3 CA
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Contact Nadezda Ivanova
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Regulation Number 870.1875

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Classification Product Code DQD
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Date Received 09/22/2022
Decision Date 03/29/2023
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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