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FDA 510(k) Application Details - K103434
Device Classification Name
Ventilator, Non-Continuous (Respirator)
More FDA Info for this Device
510(K) Number
K103434
Device Name
Ventilator, Non-Continuous (Respirator)
Applicant
3B PRODUCTS, LLC
1142 N SCENIC HIGHWAY
LAKE WALES, FL 33853 US
Other 510(k) Applications for this Company
Contact
ALBERT ALEXANDER LUCIO
Other 510(k) Applications for this Contact
Regulation Number
868.5905
More FDA Info for this Regulation Number
Classification Product Code
BZD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/23/2010
Decision Date
10/13/2011
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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