FDA.reportPublic FDA data

510(k) K863825

Device
CO-OXIMETER SOLUTIONS
Applicant
D.R.G. SCIENTIFIC INDUSTRIES
510(k) number
K863825
Product code
JKS  
Decision
Substantially Equivalent (SESE)
Decision date
1986-11-24
Date received
1986-09-30
Regulation
862.3220
Classification name
Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-monoxide
Medical specialty
Toxicology
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
VINCENT E CORSANO
Address
1140 Saratoga St. East Boston MA US 02128 02128

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JKS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K951485AVOXIMETER 4000A-Vox Systems, Inc.1995-11-06
K862253IL 482 CO-OXIMETERInstrumentation Laboratory CO1986-07-29
K853990OSM3 HEMOXIMETERRadiometer America, Inc.1985-12-30
K833693TEE ADAPTER 9890-FLUSH WINDING 282Shaban Mfg. Co.1983-12-30
K833211BILE SALTS MIXTUREAcumedia Manufacturers, Inc.1983-10-27
K832066CONTROL 282Bio-Nustics, Inc.1983-09-29
K780652HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2The London Co.1978-07-27

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