WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES

System, Measurement, Blood-pressure, Non-invasive

WELCH ALLYN, INC.

The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Spot Vital Signs Lxi Model 45000 Series.

Pre-market Notification Details

Device IDK101680
510k NumberK101680
Device Name:WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls,  NY  13153 -0220
ContactHuy Doan
CorrespondentHuy Doan
WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls,  NY  13153 -0220
Product CodeDXN  
Subsequent Product CodeDQA
Subsequent Product CodeFLL
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-06-15
Decision Date2010-07-09
Summary:summary

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