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 Oct 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
Oct 13, 1982
Date Received
Aug 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 (Jan 13, 2012)
  • K963049 — STERI-AID KIT (Nov 12, 1996)
  • K946046 — DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIP (Jul 19, 1995)
  • K894893 — POINT CHECKER COLOR STRIP THERMOMETER (Apr 5, 1990)
  • K884612 — FRANKLIN COLLECTOR(R) (Mar 27, 1989)
  • K881286 — TEMPA-DOT CLINICAL THERMOMETER SHEATH (Jun 8, 1988)
  • K863181 — HEALTHCHECK THERM-STRIP (Sep 11, 1986)
  • K853515 — PEE WEE THERMOMETERS (Oct 16, 1985)
  • K791574 — MODIFIED TEMPA-DOT THERMOMETER (Sep 12, 1979)
  • K790890 — TEMPO2-I DISPOSABLE THERMOMETERS (Jun 27, 1979)

FDA data resources