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510(k) K864853

OMNI THERM TEMPERATURE MONITOR by Omni Therm, Inc. — Product Code KPD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1987
Date Received
December 11, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Strip, Temperature, Forehead, Liquid Crystal
Device Class
Class II
Regulation Number
880.2200
Review Panel
HO
Submission Type

Other clearances by Omni Therm, Inc.

  • K961176 — OMNI COLD GEL PACKS (September 4, 1996)
  • K955788 — IMNI HOT PACKS (September 4, 1996)
  • K954877 — OMNI COLD GEL PACKS (February 13, 1996)
  • K936084 — OMNI WARM GEL PACKS (March 31, 1994)

Other clearances for product code KPD

  • K934941 — E-Z TEMP II (July 27, 1994)
  • K903307 — TEMP MARQ TEMPERATURE TREND INDICATOR (August 17, 1990)
  • K893803 — FEVER LINE AND FEVER LINE PLUS (August 21, 1989)
  • K850797 — TEMPALERT LIQUID CRYSTAL THERMOMETER (April 5, 1985)
  • K841913 — TEMPTREND PEDS AXILLARY TEMP. INDICATOR (November 2, 1984)
  • K833904 — TEMPTREND II (December 27, 1983)
  • K832651 — ATI FOREHEAD THERMOMETER (October 4, 1983)
  • K823221 — ACCA-TEMP SKIN TEMP. VINYL DISC (January 12, 1983)
  • K821312 — TEMPTREND TEMPERATURE TREND INDICATOR (May 28, 1982)
  • K820426 — TEMPERATURE TREND INDICATOR (TTI) (March 8, 1982)