BIS QUATRO SENSOR

Electrode, Cutaneous

ASPECT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Aspect Medical Systems, Inc. with the FDA for Bis Quatro Sensor.

Pre-market Notification Details

Device IDK093183
510k NumberK093183
Device Name:BIS QUATRO SENSOR
ClassificationElectrode, Cutaneous
Applicant ASPECT MEDICAL SYSTEMS, INC. 1 UPLAND ROAD Norwood,  MA  02062
ContactVikram Verma
CorrespondentCasey Conry
UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville,  NY  11747
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-10-09
Decision Date2009-10-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521134505 K093183 000
10884521133884 K093183 000
90884521211267 K093183 000
90884521722961 K093183 000
10884521134317 K093183 000
10884521134324 K093183 000

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