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FDA 510(k) Application Details - K961975
Device Classification Name
Pump, Infusion
More FDA Info for this Device
510(K) Number
K961975
Device Name
Pump, Infusion
Applicant
DISETRONIC MEDICAL SYSTEMS
32 HEMLOCK ST.
LONDONDERRY, NH 03053-3750 US
Other 510(k) Applications for this Company
Contact
WALTER PISKORSKI
Other 510(k) Applications for this Contact
Regulation Number
880.5725
More FDA Info for this Regulation Number
Classification Product Code
FRN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/20/1996
Decision Date
01/30/1997
Decision
ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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