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510(k) K791190

STETHOSCOPE WITH TEMPERATURE SENSOR by National Catheter Co. Div. Mallinckrodt — Product Code BZT

K791190 is an FDA 510(k) premarket notification submitted by National Catheter Co. Div. Mallinckrodt for the device "STETHOSCOPE WITH TEMPERATURE SENSOR". The FDA issued a decision of Substantially Equivalent on July 6, 1979. The device falls under product code BZT (Stethoscope, Esophageal, With Electrical Conductors), a Class II device regulated under 21 CFR 868.1920. National Catheter Co. Div. Mallinckrodt has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1979
Date Received
June 26, 1979
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 National Catheter Co. Div. Mallinckrodt

  • K802918 — ANTHRON CATHETER SET (April 21, 1981)
  • K802505 — DOUBLE LUMEN TRACHEAL TUBE (March 13, 1981)
  • K810321 — REINFORCED TRACHEOSTOMY TUBE SET(TENTAT) (March 4, 1981)
  • K801924 — HI-LO TEMP GEN. PURPOSE TEMP. PROBE (September 9, 1980)
  • K801005 — MLT TUBE MICROLARYNGEAL TRACHEAL TUBE) (May 23, 1980)
  • K781665 — TUBE, LEATHERMAN/IMBRUCE (December 15, 1978)
  • K770727 — MANIPULATOR & INJECTOR, UTERINE (April 26, 1977)

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