VOLUMETRIC CONTROLLER

Bag, Reservoir

QUEST MEDICAL, INC.

The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Volumetric Controller.

Pre-market Notification Details

Device IDK822216
510k NumberK822216
Device Name:VOLUMETRIC CONTROLLER
ClassificationBag, Reservoir
Applicant QUEST MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeBTC  
CFR Regulation Number868.5320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-07-26
Decision Date1982-08-16

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