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510(k) K904943

TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE by Arzco Medical Electronics, Inc. — Product Code BZT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1991
Date Received
November 1, 1990
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 Arzco Medical Electronics, Inc.

  • K905831 — ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH (March 29, 1991)
  • K903136 — ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER (January 18, 1991)

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  • 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)