FREEDOM OXIMETER/EEG DIGITAL INTERFACE

Oximeter

PRO-TECH, INC.

The following data is part of a premarket notification filed by Pro-tech, Inc. with the FDA for Freedom Oximeter/eeg Digital Interface.

Pre-market Notification Details

Device IDK924752
510k NumberK924752
Device Name:FREEDOM OXIMETER/EEG DIGITAL INTERFACE
ClassificationOximeter
Applicant PRO-TECH, INC. P.O. BOX 2165 17710-134TH AVENUE N.E. Woodinville,  WA  98072
ContactRandy Carruthers
CorrespondentRandy Carruthers
PRO-TECH, INC. P.O. BOX 2165 17710-134TH AVENUE N.E. Woodinville,  WA  98072
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-23
Decision Date1993-09-10

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