MODIFIED STBP-680

System, Measurement, Blood-pressure, Non-invasive

QUINTON, INC.

The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Modified Stbp-680.

Pre-market Notification Details

Device IDK863891
510k NumberK863891
Device Name:MODIFIED STBP-680
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant QUINTON, INC. 2121 TERRY AVE. Seatle,  WA  98121
ContactRandy Walls
CorrespondentRandy Walls
QUINTON, INC. 2121 TERRY AVE. Seatle,  WA  98121
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-10-06
Decision Date1987-02-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.