OXIMAX 700

Oximeter

PACE TECH, INC.

The following data is part of a premarket notification filed by Pace Tech, Inc. with the FDA for Oximax 700.

Pre-market Notification Details

Device IDK900866
510k NumberK900866
Device Name:OXIMAX 700
ClassificationOximeter
Applicant PACE TECH, INC. 1060 CEPHAS RD. Clearwater,  FL  34625
ContactMary J Bilgutay
CorrespondentMary J Bilgutay
PACE TECH, INC. 1060 CEPHAS RD. Clearwater,  FL  34625
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-23
Decision Date1990-04-04

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