FDA.reportPublic FDA data

510(k) K032789

Device
REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469
Applicant
American I.V. Products, Inc.
510(k) number
K032789
Product code
FRN
Decision
Substantially Equivalent (SESE)
Decision date
2003-10-09
Date received
2003-09-08
Regulation
880.5725
Classification name
Pump, Infusion
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GREGORY FALK
Address
7485 Shipley Ave. Hanover MD US 21076 21076

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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