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510(k) K082951

IMMERSION HYDROBATH by Arjo Hospital Equipment AB — Product Code ILJ

K082951 is an FDA 510(k) premarket notification submitted by Arjo Hospital Equipment AB for the device "IMMERSION HYDROBATH". The FDA issued a decision of Substantially Equivalent on April 8, 2009. The device falls under product code ILJ (Bath, Hydro-Massage), a Class II device regulated under 21 CFR 890.5100.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2009
Date Received
October 3, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bath, Hydro-Massage
Device Class
Class II
Regulation Number
890.5100
Review Panel
PM
Submission Type

Other clearances for product code ILJ

  • K110994 — PARKER 500 (July 6, 2011)
  • K052479 — MBATH 1000 (60) (January 26, 2006)
  • K040772 — PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM (April 5, 2004)
  • K012057 — CASCADE BATH, MODEL 6900 (July 19, 2001)
  • K012061 — SUPERIOR BATH, MODEL 6300 (July 19, 2001)
  • K001079 — RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO (May 1, 2000)
  • K993872 — VANNA BATHING SYSTEM (February 16, 2000)
  • K992779 — A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM (January 13, 2000)
  • K991184 — HYDROTONE-THERMAL CAPSULE SYSTEM (June 23, 1999)
  • K980909 — VICHY SHOWER (August 11, 1998)

FDA data resources