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FDA 510(k) Application Details - K223049
Device Classification Name
Recorder, Magnetic Tape, Medical
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510(K) Number
K223049
Device Name
Recorder, Magnetic Tape, Medical
Applicant
Icentia Inc.
2750 Einstein St
Quebec G1P4R1 CA
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Contact
DaniΦle Grondines
Other 510(k) Applications for this Contact
Regulation Number
870.2800
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Classification Product Code
DSH
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More FDA Info for this Product Code
Date Received
09/29/2022
Decision Date
03/22/2023
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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