FLEXICAIR EXLIPSE

Bed, Flotation Therapy, Powered

HILL-ROM, INC.

The following data is part of a premarket notification filed by Hill-rom, Inc. with the FDA for Flexicair Exlipse.

Pre-market Notification Details

Device IDK951001
510k NumberK951001
Device Name:FLEXICAIR EXLIPSE
ClassificationBed, Flotation Therapy, Powered
Applicant HILL-ROM, INC. 4349 CORPORATE RD. Charleston,  SC  29405
ContactEdwin Bills
CorrespondentEdwin Bills
HILL-ROM, INC. 4349 CORPORATE RD. Charleston,  SC  29405
Product CodeIOQ  
CFR Regulation Number890.5170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-03
Decision Date1995-06-27

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