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FDA 510(k) Application Details - K060546
Device Classification Name
Ventilator, Continuous, Non-Life-Supporting
More FDA Info for this Device
510(K) Number
K060546
Device Name
Ventilator, Continuous, Non-Life-Supporting
Applicant
BREAS MEDICAL AB
FORETAGSVAGEN 1
MOLNLYCKE, VASTRA GOTALAND SE-435 33 SE
Other 510(k) Applications for this Company
Contact
KARL-JOHAN HOLM
Other 510(k) Applications for this Contact
Regulation Number
868.5895
More FDA Info for this Regulation Number
Classification Product Code
MNS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/01/2006
Decision Date
05/26/2006
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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