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510(k) K993104

Device
STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR
Applicant
NOVA BIOMEDICAL CORP.
510(k) number
K993104
Product code
GLY  
Decision
Substantially Equivalent (SESE)
Decision date
1999-12-02
Date received
1999-09-16
Regulation
864.7500
Classification name
Oximeter To Measure Hemoglobin
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
PAUL W MAC DONALD
Address
200 Prospect St. Walham MA US 02454 02454

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GLY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K050014HEMONIR TMNir Diagnostics, Inc.2005-05-05
K955013NOVA CO-OXIMETER ANALYZERNova Biomedical Corp.1996-04-25
K952725MULTICHECKRadiometer America, Inc.1996-02-20
K895466AVL MODEL 912 CO-OXYLITEAvl Scientific Corp.1989-11-06

Legacy Summary#

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FDA Review#

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