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510(k) K946046

DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIP by Deroyal Critical Care, Div. Deroyal Technologies — Product Code FQZ

K946046 is an FDA 510(k) premarket notification submitted by Deroyal Critical Care, Div. Deroyal Technologies for the device "DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIP". The FDA issued a decision of Substantially Equivalent on July 19, 1995. 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
July 19, 1995
Date Received
December 12, 1994
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)
  • 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)
  • K790890 — TEMPO2-I DISPOSABLE THERMOMETERS (June 27, 1979)

FDA data resources