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510(k) K860558

ESOPHAGEAL STETHOSCOPE by Sharn, Inc. — Product Code BZW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1986
Date Received
February 14, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stethoscope, Esophageal
Device Class
Class I
Regulation Number
868.1910
Review Panel
AN
Submission Type

Other clearances by Sharn, Inc.

  • K070596 — TOPICAL APPLICATOR (June 21, 2007)
  • K932305 — VILA-COOKE(TM) ANESTHESIA PILLOW (October 5, 1993)
  • K894032 — EVAC-TUBE (August 31, 1989)

Other clearances for product code BZW

  • K874519 — MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR (January 29, 1988)
  • K844444 — ESOPHAGEAL STETHOSCOPE (January 10, 1985)
  • K843070 — ESOPHAGEAL STETHOSCOPES (August 24, 1984)
  • K841574 — QUAZAR ESOPHAGEAL STETHOSCOPE (August 15, 1984)
  • K842865 — ESOPHAGEAL STETHOSCOPE (August 15, 1984)
  • K830329 — ESOPHAGEAL STETHOSCOPE (March 11, 1983)
  • K830218 — SHERIDAN/ESOPHAGEAL STETHOSCOPE (March 9, 1983)
  • K823703 — ESOPHAGEAL STETHOSCOPE (January 7, 1983)
  • K823126 — MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER (November 16, 1982)
  • K800463 — ESOPHAGEAL STETHESCOPE (March 10, 1980)