FDA.reportPublic FDA data

510(k) K852232

Device
PRESSURE DISPLAY BOX #60000/TUBING SET #61000
Applicant
DLP, INC.
510(k) number
K852232
Product code
DXS  
Decision
Substantially Equivalent (SESE)
Decision date
1985-08-09
Date received
1985-05-22
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#

Contact
RONALD A WILLIAMS
Address
P.O.Box 409 620 Watsons SW Grand Rapids MI US 49501 49501

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
K842194PRESSURE MONITORNorton Texas Medical Products1984-08-27
K831750PM-3Delta Medical Industries1983-07-26
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#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases