FDA.reportPublic FDA data

510(k) K790936

Device
MODEL 114 TREONIC H150 HAEMOHEATER
Applicant
VICKERS AMERICA MEDICAL CORP.
510(k) number
K790936
Product code
KZL  
Decision
Substantially Equivalent (SESE)
Decision date
1979-09-04
Date received
1979-05-18
Regulation
864.9205
Classification name
Device, Warming. Blood And Plasma
Medical specialty
Hematology
Review panel
Hematology
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 KZL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K813489ROCKING/CIRCULATING CYTO-THERM II 3570Cryosan, Inc.1982-03-04
K812311CIRCULATING CYTO-THERMSCryosan, Inc.1981-09-16
K800699FLO TEM (FLUID WARNER)Chroma Products, Inc.1980-05-08

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