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510(k) K843071

ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR by Primrose Medical, Inc. — Product Code BZT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1984
Date Received
August 6, 1984
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 Primrose Medical, Inc.

  • K884715 — ACHELASIA BALLOON DIALATOR (September 29, 1989)
  • K884713 — COLONIC BALLOON DIALATORS (September 29, 1989)
  • K884714 — BILIARY DIALATOR (September 29, 1989)
  • K884711 — URETHRAL AND URETERAL BALLOON DILATATORS (September 29, 1989)
  • K884712 — ESOPHAGEAL AND PYLORIC BALLOON DIALATORS (September 8, 1989)
  • K884709 — ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) (September 8, 1989)
  • K883420 — LANCET, BLOOD (August 26, 1988)
  • K881976 — CATHETER, INTRAVASCULAR (August 4, 1988)
  • K881977 — PRESSURE INFUSOR (July 29, 1988)
  • K881975 — SET, INTRAVASCULAR (July 29, 1988)

Other clearances for product code BZT

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  • 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)