VITALMAX 530

Oximeter

PACE TECH MEDICAL MONITORS, INC.

The following data is part of a premarket notification filed by Pace Tech Medical Monitors, Inc. with the FDA for Vitalmax 530.

Pre-market Notification Details

Device IDK932203
510k NumberK932203
Device Name:VITALMAX 530
ClassificationOximeter
Applicant PACE TECH MEDICAL MONITORS, INC. 510 GARDEN AVE. NORTH Clearwater,  FL  34615 -4126
ContactMary Bilgutay
CorrespondentMary Bilgutay
PACE TECH MEDICAL MONITORS, INC. 510 GARDEN AVE. NORTH Clearwater,  FL  34615 -4126
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-06
Decision Date1994-07-19

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