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FDA 510(k) Application Details - K182394
Device Classification Name
Ventilator, Non-Continuous (Respirator)
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510(K) Number
K182394
Device Name
Ventilator, Non-Continuous (Respirator)
Applicant
Apex Medical Corp.
No. 9 Min Sheng St. Tu-Cheng
New Taipei City 23679 TW
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Contact
Frank Lin
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Regulation Number
868.5905
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Classification Product Code
BZD
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More FDA Info for this Product Code
Date Received
09/04/2018
Decision Date
05/17/2019
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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