FDA 510(k) Application Details - K211779

Device Classification Name Stethoscope, Electronic

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510(K) Number K211779
Device Name Stethoscope, Electronic
Applicant Chip Ideas Electronics S.L.
Calle Alfareria 3 B
Burjasot 46100 ES
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Contact Bernardo Plaza Trillo
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Regulation Number 870.1875

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Classification Product Code DQD
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Date Received 06/09/2021
Decision Date 05/26/2022
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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