RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO

Bath, Hydro-massage

ARJO, INC.

The following data is part of a premarket notification filed by Arjo, Inc. with the FDA for Recumbent Bathing Systems, Rhapsody And Primo.

Pre-market Notification Details

Device IDK001079
510k NumberK001079
Device Name:RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO
ClassificationBath, Hydro-massage
Applicant ARJO, INC. 50 NORTH GARY AVE., SUITE A Roselle,  IL  60172 -1684
ContactDavid Insco
CorrespondentDavid Insco
ARJO, INC. 50 NORTH GARY AVE., SUITE A Roselle,  IL  60172 -1684
Product CodeILJ  
CFR Regulation Number890.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-04-04
Decision Date2000-05-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05055982728560 K001079 000

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