QUINTON Q.CATH

Computer, Diagnostic, Programmable

QUINTON, INC.

The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Quinton Q.cath.

Pre-market Notification Details

Device IDK862740
510k NumberK862740
Device Name:QUINTON Q.CATH
ClassificationComputer, Diagnostic, Programmable
Applicant QUINTON, INC. 2121 TERRY AVE. Seatle,  WA  98121
ContactDonald L Andersen
CorrespondentDonald L Andersen
QUINTON, INC. 2121 TERRY AVE. Seatle,  WA  98121
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-07-21
Decision Date1986-10-31

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