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510(k) K820426

TEMPERATURE TREND INDICATOR (TTI) by Mon-A-Therm, Inc. — Product Code KPD

K820426 is an FDA 510(k) premarket notification submitted by Mon-A-Therm, Inc. for the device "TEMPERATURE TREND INDICATOR (TTI)". The FDA issued a decision of Substantially Equivalent on March 8, 1982. The device falls under product code KPD (Strip, Temperature, Forehead, Liquid Crystal), a Class II device regulated under 21 CFR 880.2200. Mon-A-Therm, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1982
Date Received
February 16, 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 Mon-A-Therm, Inc.

  • K885187 — MODEL 1000 ELECTRONIC CLINICAL THERMOMETER (March 8, 1989)
  • K874522 — MODIFIED MYOCARDIAL TEMPERATURE SENSOR (January 29, 1988)
  • K874519 — MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR (January 29, 1988)
  • K875234 — MON-A-THERM'S SKIN TEMPERATURE SENSOR (January 19, 1988)
  • K874523 — MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSOR (January 6, 1988)
  • K874524 — MODIFIED SUBCUTANEOUS TEMPERATURE SENSOR (January 6, 1988)
  • K874525 — MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR (January 6, 1988)
  • K874521 — MODIFIED THERMAL WELL TEMPERATURE SENSOR (January 6, 1988)
  • K874520 — MODIFIED AIRWAY TEMPERATURE SENSOR (January 6, 1988)
  • K853392 — MON-A-THERM SUBCUTANEOUS TEMP. SENSOR (November 22, 1985)

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)
  • K823221 — ACCA-TEMP SKIN TEMP. VINYL DISC (January 12, 1983)
  • K821312 — TEMPTREND TEMPERATURE TREND INDICATOR (May 28, 1982)

FDA data resources