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510(k) K082951

Device
IMMERSION HYDROBATH
Applicant
Arjo Hospital Equipment AB
510(k) number
K082951
Product code
ILJ
Decision
Substantially Equivalent (SESE)
Decision date
2009-04-08
Date received
2008-10-03
Regulation
890.5100
Classification name
Bath, Hydro-Massage
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
TRACI GIOVENCO
Address
50 N. Gary Ave., Suite A Roselle IL US 60172 60172

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ILJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K110994PARKER 500Arjohuntleigh, Inc.2011-07-06
K052479MBATH 1000 (60)Enneking Medical, Inc.2006-01-26
K040772PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEMPenner Manufacturing, Inc.2004-04-05
K012057CASCADE BATH, MODEL 6900Penner Manufacturing, Inc.2001-07-19
K012061SUPERIOR BATH, MODEL 6300Penner Manufacturing, Inc.2001-07-19
K001079RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMOArjo, Inc.2000-05-01
K993872VANNA BATHING SYSTEMVancare, Inc.2000-02-16
K992779A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEMMedi-Man Rehabilitation Products, Inc.2000-01-13
K991184HYDROTONE-THERMAL CAPSULE SYSTEMNats Corp.1999-06-23
K980909VICHY SHOWERBouvier Hydro, Inc.1998-08-11
K980920EQUINOXEBouvier Hydro, Inc.1998-07-16
K974321HYDROTONENorth American Technical Services Corp.1998-06-22
K980033FERNO HEALTHCARE RECLINE-A-BATH 2Ferno-Washington, Inc.1998-04-21
K980769WINDMERE MODEL DS-2 FOOT BATHWindmere Corp.1998-03-27
K971593SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANTThe Silcraft Corp.1998-02-26