Home / 510(k) Clearances / K822423

510(k) K822423

BABY TEMP PACIFIER by Trp Energy Sensors, Inc. — Product Code FQZ

K822423 is an FDA 510(k) premarket notification submitted by Trp Energy Sensors, Inc. for the device "BABY TEMP PACIFIER". The FDA issued a decision of Substantially Equivalent on October 13, 1982. 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
October 13, 1982
Date Received
August 12, 1982
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)
  • 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)
  • K791574 — MODIFIED TEMPA-DOT THERMOMETER (September 12, 1979)
  • K790890 — TEMPO2-I DISPOSABLE THERMOMETERS (June 27, 1979)

FDA data resources