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FDA 510(k) Application Details - K202219
Device Classification Name
Ventilator, Emergency, Powered (Resuscitator)
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510(K) Number
K202219
Device Name
Ventilator, Emergency, Powered (Resuscitator)
Applicant
Vortran Medical Technology 1, Inc.
21 Goldenland Court, Suite 100
Sacramento, CA 95834 US
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Contact
Adam Palumbo
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Regulation Number
868.5925
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Classification Product Code
BTL
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More FDA Info for this Product Code
Date Received
08/06/2020
Decision Date
02/11/2021
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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