Q-PLEX 1

Calculator, Pulmonary Function Data

QUINTON, INC.

The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Q-plex 1.

Pre-market Notification Details

Device IDK881235
510k NumberK881235
Device Name:Q-PLEX 1
ClassificationCalculator, Pulmonary Function Data
Applicant QUINTON, INC. 2121 TERRY AVE. Seatle,  WA  98121
ContactRon R Duck
CorrespondentRon R Duck
QUINTON, INC. 2121 TERRY AVE. Seatle,  WA  98121
Product CodeBZC  
CFR Regulation Number868.1880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-22
Decision Date1989-03-31

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