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FDA 510(k) Application Details - K210179
Device Classification Name
Recorder, Magnetic Tape, Medical
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510(K) Number
K210179
Device Name
Recorder, Magnetic Tape, Medical
Applicant
Quanta Computer Inc.
No. 188, Wenhua 2nd Road, Guishan District
Taoyuan City 33377 TW
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Contact
Vivian Yang
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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
01/22/2021
Decision Date
08/02/2022
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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