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510(k) K831402

Device
PRESSURE MONITOR & CONTROL UNIT APC-02A
Applicant
PARKER HANNIFIN CORP.
510(k) number
K831402
Product code
KXM  
Decision
Substantially Equivalent (SESE)
Decision date
1983-08-08
Date received
1983-05-02
Regulation
876.5820
Classification name
System Accessories, Extracorporeal
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 KXM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K925581BAXTER BIOSTAT 1000 UREA MONITORBaxter Healthcare Corp1995-05-03
K863471COLORADO MEDICAL MODEL PTC 1000Colorado Medical, Inc.1986-10-02
K853536VELCRO FISTULA PRESSURE CLAMPSCp Medical1985-10-17

Legacy Summary#

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FDA Review#

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