FDA.reportPublic FDA data

510(k) K952725

Device
MULTICHECK
Applicant
RADIOMETER AMERICA, INC.
510(k) number
K952725
Product code
GLY  
Decision
Substantially Equivalent (SESE)
Decision date
1996-02-20
Date received
1995-06-14
Regulation
864.7500
Classification name
Oximeter To Measure Hemoglobin
Medical specialty
Hematology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DONALD L BAKER
Address
810 Sharon Dr. Westlake OH US 44145 44145

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GLY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K050014HEMONIR TMNir Diagnostics, Inc.2005-05-05
K993104STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATORNova Biomedical Corp.1999-12-02
K955013NOVA CO-OXIMETER ANALYZERNova Biomedical Corp.1996-04-25
K895466AVL MODEL 912 CO-OXYLITEAvl Scientific Corp.1989-11-06

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