AVOXIMETER 4000

Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-monoxide

A-VOX SYSTEMS, INC.

The following data is part of a premarket notification filed by A-vox Systems, Inc. with the FDA for Avoximeter 4000.

Pre-market Notification Details

Device IDK951485
510k NumberK951485
Device Name:AVOXIMETER 4000
ClassificationSpectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-monoxide
Applicant A-VOX SYSTEMS, INC. 15315 GREY FOX TERRACE San Antonio,  TX  78255
ContactA. P Shepherd
CorrespondentA. P Shepherd
A-VOX SYSTEMS, INC. 15315 GREY FOX TERRACE San Antonio,  TX  78255
Product CodeJKS  
CFR Regulation Number862.3220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-30
Decision Date1995-11-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950813590 K951485 000
08426950452614 K951485 000
08426950452577 K951485 000
08426950088684 K951485 000
08426950490791 K951485 000
10711234530054 K951485 000
10711234160053 K951485 000
10711234160046 K951485 000
10711234160039 K951485 000

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