WALLABY 4

Unit, Neonatal Phototherapy

RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP

The following data is part of a premarket notification filed by Respironics Inc., Sleep & Home Respiratory Group with the FDA for Wallaby 4.

Pre-market Notification Details

Device IDK070180
510k NumberK070180
Device Name:WALLABY 4
ClassificationUnit, Neonatal Phototherapy
Applicant RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1001 MURRY RIDGE LN. Murrysville,  PA  15668
ContactZita A Yurko
CorrespondentZita A Yurko
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1001 MURRY RIDGE LN. Murrysville,  PA  15668
Product CodeLBI  
CFR Regulation Number880.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-19
Decision Date2007-05-18
Summary:summary

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