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510(k) K973839

DISPOSABLE ESOPHAGEAL STETHOSCOPE by Catheter Research, Inc. — Product Code BZT

K973839 is an FDA 510(k) premarket notification submitted by Catheter Research, Inc. for the device "DISPOSABLE ESOPHAGEAL STETHOSCOPE". The FDA issued a decision of Substantially Equivalent on March 19, 1998. The device falls under product code BZT (Stethoscope, Esophageal, With Electrical Conductors), a Class II device regulated under 21 CFR 868.1920. Catheter Research, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1998
Date Received
October 8, 1997
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 Catheter Research, Inc.

  • K123258 — THE ADVANCE CATHETER FOR HSG AND SIS (January 31, 2013)
  • K120154 — INTRAUTERINE INSEMINATION (IUI) CATHETER (March 21, 2012)
  • K032835 — H/S CATHETER SET (December 11, 2003)
  • K020292 — UTERINE INJECTOR (April 17, 2002)
  • K974357 — UTERINE MANIPULATOR/INJECTOR (February 2, 1998)
  • K951345 — DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING (April 14, 1995)
  • K946044 — DISPOSABLE GAS SAMPLING LINES (December 27, 1994)

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)
  • K072621 — ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE (December 13, 2007)
  • K062020 — LIFESOUND ESOPHAGEAL STETHOSCOPE (September 5, 2006)
  • K982193 — ESOPHAGEAL STETHOSCOPE (September 1, 1998)
  • K961060 — ARISTO ESOPHAGEAL STETHOSCOPE (June 19, 1996)
  • K953793 — INTROSCOPE (November 29, 1995)

FDA data resources