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510(k) K861541

SHERIDAN - YSI/ECG SONATEMP (TM) by Sheridan Catheter Corp. — Product Code BZT

K861541 is an FDA 510(k) premarket notification submitted by Sheridan Catheter Corp. for the device "SHERIDAN - YSI/ECG SONATEMP (TM)". The FDA issued a decision of Substantially Equivalent on June 16, 1986. The device falls under product code BZT (Stethoscope, Esophageal, With Electrical Conductors), a Class II device regulated under 21 CFR 868.1920. Sheridan Catheter Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1986
Date Received
April 24, 1986
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 Sheridan Catheter Corp.

  • K922894 — LAZER-TRACH TRACHEAL TUBE (May 7, 1993)
  • K897046 — LASER RESISTANT TRACHEAL TUBE (March 23, 1990)
  • K890823 — ACCESSORY TO CLINICAL ELECTRONIC THERMOMETER (May 5, 1989)
  • K884765 — CLINICAL ELECTRONIC THERMOMETERS (February 16, 1989)
  • K882918 — KIM NASO-INTESTINAL TUBE (December 5, 1988)
  • K882127 — CLINICAL ELECTRONIC THERMOMETERS (August 4, 1988)
  • K881368 — CLINICAL ELECTONIC THERMOMETERS (July 13, 1988)
  • K881293 — SHERIDAN ELECTROSURGERY PROTECTION FILTER (June 16, 1988)
  • K881873 — INTRODUCTION/DRAINAGE CATHETER & ACCESS (May 18, 1988)
  • K880960 — NDYAG LASER TRACHEAL TUBE (April 29, 1988)

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)
  • K973839 — DISPOSABLE ESOPHAGEAL STETHOSCOPE (March 19, 1998)
  • K961060 — ARISTO ESOPHAGEAL STETHOSCOPE (June 19, 1996)

FDA data resources