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510(k) K771037

THERMOMETER, SINGLE USE, STRIP, TEMPADOT by Info-Chem — Product Code FQZ

K771037 is an FDA 510(k) premarket notification submitted by Info-Chem for the device "THERMOMETER, SINGLE USE, STRIP, TEMPADOT". The FDA issued a decision of Substantially Equivalent on June 27, 1977. 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
June 27, 1977
Date Received
June 10, 1977
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)
  • K791574 — MODIFIED TEMPA-DOT THERMOMETER (September 12, 1979)
  • K772233 — THERMOMETER RECAL ADAPTER (December 20, 1977)
  • K771080 — STEAM STERILIZATION INDICATOR (July 14, 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)
  • K791574 — MODIFIED TEMPA-DOT THERMOMETER (September 12, 1979)

FDA data resources