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FDA 510(k) Application Details - K221614
Device Classification Name
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510(K) Number
K221614
Device Name
TytoCare Lung Sounds Analyzer
Applicant
Tyto Care Ltd.
14 Beni Gaon Street
Netanya 4250803 IL
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Contact
Stella Raizelman Perry
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Regulation Number
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Classification Product Code
PHZ
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Date Received
06/03/2022
Decision Date
02/24/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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