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510(k) K011666

CHILLIT by Heatshield, Inc. — Product Code EAT

K011666 is an FDA 510(k) premarket notification submitted by Heatshield, Inc. for the device "CHILLIT". The FDA issued a decision of Substantially Equivalent on August 6, 2001. 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
August 6, 2001
Date Received
May 30, 2001
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)
  • 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)
  • K950238 — GENTAL PULSE (May 9, 1995)

FDA data resources