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510(k) K951485

Device
AVOXIMETER 4000
Applicant
A-VOX SYSTEMS, INC.
510(k) number
K951485
Product code
JKS  
Decision
Substantially Equivalent (SESE)
Decision date
1995-11-06
Date received
1995-03-30
Regulation
862.3220
Classification name
Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-monoxide
Medical specialty
Toxicology
Review panel
Toxicology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
A. P SHEPHERD
Address
15315 Grey Fox Ter. San Antonio TX US 78255 78255

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
K863825CO-OXIMETER SOLUTIONSD.R.G. Scientific Industries1986-11-24
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#

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FDA Review#

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