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510(k) K832651

ATI FOREHEAD THERMOMETER by American Thermal Instruments, Inc. — Product Code KPD

K832651 is an FDA 510(k) premarket notification submitted by American Thermal Instruments, Inc. for the device "ATI FOREHEAD THERMOMETER". The FDA issued a decision of Substantially Equivalent on October 4, 1983. The device falls under product code KPD (Strip, Temperature, Forehead, Liquid Crystal), a Class II device regulated under 21 CFR 880.2200. American Thermal Instruments, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1983
Date Received
August 8, 1983
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 American Thermal Instruments, Inc.

  • K832731 — BREAST & BODY HEALTH SYSTEM 2000 (January 30, 1984)

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)
  • 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