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FDA 510(k) Application Details - K051559
Device Classification Name
Ventilator, Non-Continuous (Respirator)
More FDA Info for this Device
510(K) Number
K051559
Device Name
Ventilator, Non-Continuous (Respirator)
Applicant
VITAL SIGNS COLORADO, INC.
11039 EAST LANSING CIR.
ENGLEWOOD, CO 80112 US
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Contact
TOM DIELMANN
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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
06/13/2005
Decision Date
07/08/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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