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510(k) K831404

Device
BLOOD MONITOR BMM 10-4
Applicant
GAMBRO, INC.
510(k) number
K831404
Product code
LLB  
Decision
Substantially Equivalent (SESE)
Decision date
1984-04-25
Date received
1983-05-02
Regulation
876.5820
Classification name
System, Blood, Extracorporeal And Accessories
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LLB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K991005VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO, DPC101VSDayspring Medical, Inc.1999-06-22

Legacy Summary#

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FDA Review#

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