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510(k) K831750

Device
PM-3
Applicant
DELTA MEDICAL INDUSTRIES
510(k) number
K831750
Product code
DXS  
Decision
Substantially Equivalent (SESE)
Decision date
1983-07-26
Date received
1983-06-01
Regulation
870.4310
Classification name
Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DXS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K113235PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONSMedtronic, Inc.2011-12-02
K944764VTI DISPOSABLE PRESSURE DISPLAY SETVascular Technology Incorporated1994-12-27
K912045TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYSTLifestream Int'L, Inc.1991-10-31
K900797STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XRShiley, Inc.1990-05-10
K873802PRESSURE BARRIER KIT CAT. NO. PBK-3American Omni Medical, Inc.1987-11-06
K862836STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULEShiley, Inc.1986-09-12
K852232PRESSURE DISPLAY BOX #60000/TUBING SET #61000Dlp, Inc.1985-08-09
K842194PRESSURE MONITORNorton Texas Medical Products1984-08-27
K822822GAMBRO PRESSURE MONITOR PRM 10Gambro, Inc.1982-10-18
K820912PMS-2 PRESSURE MONITOR SEPARATORDelta Medical Industries1982-05-18
K781890CHAMBER, MC-1 DISPOSABLE PRESSUREDelta Medical Industries1978-12-04
K771764CORONARY PRESSURE PERFUSION PUMP3M Health Care, Sarns1977-09-30

Legacy Summary#

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FDA Review#

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