Home / 510(k) Clearances / K072621

510(k) K072621

ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR by Cincinnati Sub-Zero Products, Inc. — Product Code BZT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2007
Date Received
September 17, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stethoscope, Esophageal, With Electrical Conductors
Device Class
Class II
Regulation Number
868.1920
Review Panel
AN
Submission Type

Other clearances by Cincinnati Sub-Zero Products, Inc.

  • K123946 — WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS (January 17, 2013)
  • K122813 — HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM (December 18, 2012)
  • K121669 — WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) (July 3, 2012)
  • K120081 — NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS (February 17, 2012)
  • K110104 — BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM (February 4, 2011)
  • K101148 — WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS (October 1, 2010)
  • K101589 — BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS (September 20, 2010)
  • K070339 — DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES (September 26, 2007)
  • K942599 — WARM AIR WARMING UNIT (January 24, 1995)
  • K942790 — WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133) (January 24, 1995)

Other clearances for product code BZT

  • K251025 — Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, (December 29, 2025)
  • K193027 — Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal St (April 2, 2020)
  • K140134 — ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSC (June 16, 2014)
  • K111050 — ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TE (April 12, 2012)
  • K092716 — ESOPHAGEAL STETHOSCOPE (September 17, 2009)
  • K062020 — LIFESOUND ESOPHAGEAL STETHOSCOPE (September 5, 2006)
  • K982193 — ESOPHAGEAL STETHOSCOPE (September 1, 1998)
  • K973839 — DISPOSABLE ESOPHAGEAL STETHOSCOPE (March 19, 1998)
  • K961060 — ARISTO ESOPHAGEAL STETHOSCOPE (June 19, 1996)
  • K953793 — INTROSCOPE (November 29, 1995)