WELCH ALLYN SPOT CHECK DEVICE

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 Check Device.

Pre-market Notification Details

Device IDK002530
510k NumberK002530
Device Name:WELCH ALLYN SPOT CHECK DEVICE
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant WELCH ALLYN, INC. 95 OLD SHOALS RD. Arden,  NC  28704
ContactJoseph D Buchanan
CorrespondentJoseph D Buchanan
WELCH ALLYN, INC. 95 OLD SHOALS RD. Arden,  NC  28704
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-08-16
Decision Date2000-11-14

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