GEM-PREMIER SYSTEM

Electrode, Ion Specific, Sodium

MALLINCKRODT SENSOR SYSTEMS, INC.

The following data is part of a premarket notification filed by Mallinckrodt Sensor Systems, Inc. with the FDA for Gem-premier System.

Pre-market Notification Details

Device IDK910305
510k NumberK910305
Device Name:GEM-PREMIER SYSTEM
ClassificationElectrode, Ion Specific, Sodium
Applicant MALLINCKRODT SENSOR SYSTEMS, INC. 1230 EISENHOWER PLACE Ann Arbor,  MI  48108
ContactBruce M Burgess
CorrespondentBruce M Burgess
MALLINCKRODT SENSOR SYSTEMS, INC. 1230 EISENHOWER PLACE Ann Arbor,  MI  48108
Product CodeJGS  
CFR Regulation Number862.1665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-24
Decision Date1991-04-03

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