RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO


information about

Device Classification Name

bath, hydro-massage

510(k) Number K001079
Device Name RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO
Original Applicant
ARJO, INC.
50 north gary ave., suite a
roselle, 
IL 
60172 -1684

Original Contact david insco
Regulation Number 890.5100
Classification Product Code
ILJ  
Date Received 04/04/2000
Decision Date 05/01/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

Type Traditional
Reviewed by Third Party No

Combination Product

No