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FDA 510(k) Application Details - K182956
Device Classification Name
Ventilator, Emergency, Powered (Resuscitator)
More FDA Info for this Device
510(K) Number
K182956
Device Name
Ventilator, Emergency, Powered (Resuscitator)
Applicant
International Biomedical
8206 Cross Park Drive
Austin, TX 78754 US
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Contact
Amy Pieper
Other 510(k) Applications for this Contact
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
10/24/2018
Decision Date
01/18/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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