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510(k) K883804

E-MITT (CONDUCTIVE HAND COVER) by The Institute For Technology Development — Product Code EAT

K883804 is an FDA 510(k) premarket notification submitted by The Institute For Technology Development for the device "E-MITT (CONDUCTIVE HAND COVER)". The FDA issued a decision of Substantially Equivalent on July 31, 1989. The device falls under product code EAT (Tester, Pulp), a Class II device regulated under 21 CFR 872.1720.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1989
Date Received
September 7, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Pulp
Device Class
Class II
Regulation Number
872.1720
Review Panel
DE
Submission Type

Other clearances for product code EAT

  • K022097 — THERMIQUE (September 6, 2002)
  • K021298 — ELEMENTS DIAGNOSTIC UNIT (June 19, 2002)
  • K012427 — PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT (October 9, 2001)
  • K011666 — CHILLIT (August 6, 2001)
  • K990225 — ENDO ANALYZER, MODEL 8005, MODIFIED (February 25, 1999)
  • K973439 — ENDO ANALYZER, MODEL 8005 (December 8, 1997)
  • K970715 — SYSTEM B HEAT SOURCE (April 7, 1997)
  • K963862 — TOUCH N' HEAT (December 2, 1996)
  • K960799 — ORTHO-ICE (May 9, 1996)
  • K950237 — DIGITEST (June 9, 1995)

FDA data resources