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510(k) K110994

PARKER 500 by Arjohuntleigh, Inc. — Product Code ILJ

K110994 is an FDA 510(k) premarket notification submitted by Arjohuntleigh, Inc. for the device "PARKER 500". The FDA issued a decision of Substantially Equivalent on July 6, 2011. 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
July 6, 2011
Date Received
April 8, 2011
Clearance Type
Abbreviated
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

  • K082951 — IMMERSION HYDROBATH (April 8, 2009)
  • K052479 — MBATH 1000 (60) (January 26, 2006)
  • K040772 — PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM (April 5, 2004)
  • K012061 — SUPERIOR BATH, MODEL 6300 (July 19, 2001)
  • K012057 — CASCADE BATH, MODEL 6900 (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