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510(k) K974321

HYDROTONE by North American Technical Services Corp. — Product Code ILJ

K974321 is an FDA 510(k) premarket notification submitted by North American Technical Services Corp. for the device "HYDROTONE". The FDA issued a decision of Substantially Equivalent on June 22, 1998. The device falls under product code ILJ (Bath, Hydro-Massage), a Class II device regulated under 21 CFR 890.5100. North American Technical Services Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1998
Date Received
November 17, 1997
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 by North American Technical Services Corp.

  • K970592 — N/A (June 13, 1997)
  • K970590 — N/A (June 13, 1997)
  • K961582 — EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 (November 8, 1996)
  • K953440 — ELLMAN LAPTRODE (August 29, 1995)
  • K944558 — ELLMAN VAPOR-VAC II (April 28, 1995)
  • K944730 — MASSAGER (February 14, 1995)
  • K932204 — E-Z THERM 3 SECOND THERMOMETER (October 3, 1994)
  • K914364 — ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO. (September 10, 1992)

Other clearances for product code ILJ

  • K110994 — PARKER 500 (July 6, 2011)
  • 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)

FDA data resources