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510(k) K943495

DISPOSABLE ESOPHAGEAL STETHOSCOPE by Coast Medical, Inc. — Product Code BZT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1994
Date Received
July 19, 1994
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 Coast Medical, Inc.

  • K952243 — EXTENSION SET/I.V. SET (July 26, 1995)
  • K930929 — ESOPHAGEAL STETHOSCOPE (March 17, 1995)
  • K944729 — STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE (December 21, 1994)
  • K943270 — SURFACE TEMPERATURE PROBES (December 5, 1994)
  • K943110 — GAS SAMPLING INTERFACES (August 19, 1994)
  • K930930 — COAST MEDICAL, INC. RECTAL PROBE (February 25, 1994)
  • K925781 — DISPOSABLE CUFFED ENDOTRACHEAL TUBE (April 19, 1993)
  • K925855 — DISPOSABLE UNCUFFED ENDOTRACHEAL TUBE (February 18, 1993)
  • K921077 — DISPOSABLE INTUBATION KITS (August 25, 1992)
  • K921353 — NASOPHARYNGEAL AIRWAY (June 11, 1992)

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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)