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510(k) K925237

AUTOMATIC CALORIC IRRIGATION SYSTEM by Ics Medical Corp. — Product Code KHH

K925237 is an FDA 510(k) premarket notification submitted by Ics Medical Corp. for the device "AUTOMATIC CALORIC IRRIGATION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 5, 1993. The device falls under product code KHH (Stimulator, Caloric-Air), a Class I device regulated under 21 CFR 874.1800. Ics Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1993
Date Received
October 16, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Caloric-Air
Device Class
Class I
Regulation Number
874.1800
Review Panel
EN
Submission Type

Other clearances by Ics Medical Corp.

  • K031986 — ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS (July 24, 2003)
  • K013060 — ICS MEDICAL MODEL VG-30 VIDEO GOGGLES (December 10, 2001)
  • K011181 — ICS MEDICAL CHARTR OAE WITH TYMP (June 25, 2001)
  • K002985 — ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS (December 13, 2000)
  • K991497 — ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM (July 28, 1999)
  • K972631 — ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER (September 22, 1997)
  • K960097 — CHARTR EP (February 21, 1997)
  • K931609 — CHARTR ENG SYSTEM (September 26, 1995)
  • K931608 — NCA-200 (June 22, 1993)
  • K881630 — AUTOMATIC CALORIC IRRIGATION SYSTEM (June 21, 1988)

Other clearances for product code KHH

  • K950785 — HORTMANN AIRMATIC AIR CALORIC STIMULATOR (June 28, 1995)
  • K946108 — EAR-A-GATOR (June 13, 1995)
  • K941325 — WATER IRRIGATOR, W1 200 (August 9, 1994)
  • K931608 — NCA-200 (June 22, 1993)
  • K881630 — AUTOMATIC CALORIC IRRIGATION SYSTEM (June 21, 1988)
  • K822179 — FRENZEL EYEGLASSES & RELATED ITEMS (September 21, 1982)

FDA data resources