WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C

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 Model 40000 Sphyg W/ 40030-35 Blad & C.

Pre-market Notification Details

Device IDK852574
510k NumberK852574
Device Name:WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls,  NY  13153 -0220
ContactRobert W Becker
CorrespondentRobert W Becker
WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls,  NY  13153 -0220
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-06-18
Decision Date1986-03-13

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