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510(k) K894757

T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE by Louisville Laboratories, Inc. — Product Code BZT

K894757 is an FDA 510(k) premarket notification submitted by Louisville Laboratories, Inc. for the device "T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE". The FDA issued a decision of Substantially Equivalent on September 18, 1989. The device falls under product code BZT (Stethoscope, Esophageal, With Electrical Conductors), a Class II device regulated under 21 CFR 868.1920. Louisville Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1989
Date Received
July 27, 1989
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 Louisville Laboratories, Inc.

  • K980123 — CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET (March 9, 1998)
  • K971796 — LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS (August 12, 1997)
  • K971802 — VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION (July 30, 1997)
  • K971791 — VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION (July 30, 1997)
  • K971801 — LAPAROTOMY BLADDER NECK SUSPENSION KIT (July 22, 1997)
  • K971797 — LAPAROSCOPIC BLADDER NECK SUSPENSION KIT (July 22, 1997)
  • K963076 — LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY (April 4, 1997)
  • K960882 — CONTROL SYRINGE (July 8, 1996)
  • K955535 — LOUISVILLE LABS OXYGEN HEAD TENT (July 1, 1996)
  • K946282 — UNIVERSAL URETHRAL CATHETER (March 31, 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)
  • 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