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510(k) K894893

POINT CHECKER COLOR STRIP THERMOMETER by Kyowa Medex Co., Ltd. — Product Code FQZ

K894893 is an FDA 510(k) premarket notification submitted by Kyowa Medex Co., Ltd. for the device "POINT CHECKER COLOR STRIP THERMOMETER". The FDA issued a decision of Substantially Equivalent on April 5, 1990. The device falls under product code FQZ (Thermometer, Clinical Color Change), a Class I device regulated under 21 CFR 880.2900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1990
Date Received
August 1, 1989
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 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)
  • 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)
  • K790890 — TEMPO2-I DISPOSABLE THERMOMETERS (June 27, 1979)

FDA data resources