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FDA 510(k) Application Details - K971168
Device Classification Name
Pump, Infusion, Elastomeric
More FDA Info for this Device
510(K) Number
K971168
Device Name
Pump, Infusion, Elastomeric
Applicant
BAXTER HEALTHCARE CORP.
P.O. BOX 490 RT. 120 AND
WILSON RD.
ROUND LAKE, IL 60073-0490 US
Other 510(k) Applications for this Company
Contact
PATRICIA S BARSANTI
Other 510(k) Applications for this Contact
Regulation Number
880.5725
More FDA Info for this Regulation Number
Classification Product Code
MEB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/31/1997
Decision Date
07/15/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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