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510(k) K823221

ACCA-TEMP SKIN TEMP. VINYL DISC by T. G. & E. Medical — Product Code KPD

K823221 is an FDA 510(k) premarket notification submitted by T. G. & E. Medical for the device "ACCA-TEMP SKIN TEMP. VINYL DISC". The FDA issued a decision of Substantially Equivalent on January 12, 1983. The device falls under product code KPD (Strip, Temperature, Forehead, Liquid Crystal), a Class II device regulated under 21 CFR 880.2200. T. G. & E. Medical has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1983
Date Received
October 29, 1982
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 T. G. & E. Medical

  • K860706 — IV BAND (INTRAVENOUS CATHETER ASSESORY) (March 21, 1986)
  • K860261 — CANNULA BAND (February 18, 1986)
  • K820941 — THERMA-SCAN (June 16, 1982)
  • K813199 — SKIN TEMPERATURE SENSING VINYL STRIP (March 5, 1982)

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)
  • K864853 — OMNI THERM TEMPERATURE MONITOR (February 4, 1987)
  • 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)
  • K821312 — TEMPTREND TEMPERATURE TREND INDICATOR (May 28, 1982)
  • K820426 — TEMPERATURE TREND INDICATOR (TTI) (March 8, 1982)

FDA data resources