A SLEEP ASSESSMENT DEVICE

Device, Sleep Assessment

FARRALL INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Farrall Instruments, Inc. with the FDA for A Sleep Assessment Device.

Pre-market Notification Details

Device IDK792305
510k NumberK792305
Device Name:A SLEEP ASSESSMENT DEVICE
ClassificationDevice, Sleep Assessment
Applicant FARRALL INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLEL  
CFR Regulation Number882.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-11-16
Decision Date1979-12-20

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