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510(k) K864853

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

K864853 is an FDA 510(k) premarket notification submitted by Omni Therm, Inc. for the device "OMNI THERM TEMPERATURE MONITOR". The FDA issued a decision of Substantially Equivalent on February 4, 1987. The device falls under product code KPD (Strip, Temperature, Forehead, Liquid Crystal), a Class II device regulated under 21 CFR 880.2200. Omni Therm, Inc. has at least 4 other 510(k) clearances on record.

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.

  • K955788 — IMNI HOT PACKS (September 4, 1996)
  • K961176 — OMNI COLD GEL 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)

FDA data resources