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510(k) K791574

MODIFIED TEMPA-DOT THERMOMETER by Info-Chem — Product Code FQZ

K791574 is an FDA 510(k) premarket notification submitted by Info-Chem for the device "MODIFIED TEMPA-DOT THERMOMETER". The FDA issued a decision of Substantially Equivalent on September 12, 1979. The device falls under product code FQZ (Thermometer, Clinical Color Change), a Class I device regulated under 21 CFR 880.2900. Info-Chem has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1979
Date Received
August 13, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thermometer, Clinical Color Change
Device Class
Class I
Regulation Number
880.2900
Review Panel
HO
Submission Type

Other clearances by Info-Chem

  • K810134 — KEEP-ACCOUNT SHARPS DISPOSAL SYSTEM (February 26, 1981)
  • K772233 — THERMOMETER RECAL ADAPTER (December 20, 1977)
  • K771080 — STEAM STERILIZATION INDICATOR (July 14, 1977)
  • K771037 — THERMOMETER, SINGLE USE, STRIP, TEMPADOT (June 27, 1977)

Other clearances for product code FQZ

  • K110305 — CRY-ACTRACKERCAM (January 13, 2012)
  • K963049 — STERI-AID KIT (November 12, 1996)
  • K946046 — DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIP (July 19, 1995)
  • K894893 — POINT CHECKER COLOR STRIP THERMOMETER (April 5, 1990)
  • K884612 — FRANKLIN COLLECTOR(R) (March 27, 1989)
  • K881286 — TEMPA-DOT CLINICAL THERMOMETER SHEATH (June 8, 1988)
  • K863181 — HEALTHCHECK THERM-STRIP (September 11, 1986)
  • K853515 — PEE WEE THERMOMETERS (October 16, 1985)
  • K822423 — BABY TEMP PACIFIER (October 13, 1982)
  • K790890 — TEMPO2-I DISPOSABLE THERMOMETERS (June 27, 1979)

FDA data resources