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510(k) K842865

ESOPHAGEAL STETHOSCOPE by Inmed Corp. — Product Code BZW

K842865 is an FDA 510(k) premarket notification submitted by Inmed Corp. for the device "ESOPHAGEAL STETHOSCOPE". The FDA issued a decision of Substantially Equivalent on August 15, 1984. The device falls under product code BZW (Stethoscope, Esophageal), a Class I device regulated under 21 CFR 868.1910. Inmed Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1984
Date Received
July 23, 1984
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 Inmed Corp.

  • K862672 — ESOPHAGEAL STETHOSCOPE WITH THERMISTOR (October 27, 1986)
  • K853162 — STERILE NASOPHARYNGEAL AIRWAY (August 6, 1985)
  • K850248 — DISPOSABLE GUEDEL AIRWAY (March 12, 1985)
  • K850335 — URETEROSCOPY CATHETER (March 12, 1985)
  • K850152 — PRECONNECTED URETHRAL CATHETER TRAY (March 12, 1985)
  • K844801 — ULTRA EXTERNAL CATHETER (January 15, 1985)
  • K842301 — DISPOSABLE LATEX BANDAGE (November 5, 1984)
  • K842866 — URETHRAL CATHETERIZATION TRAY (September 10, 1984)
  • K841040 — FOX POST NASAL BALLOON CATHETER (August 17, 1984)
  • K841037 — PENROSE DRAINS (April 25, 1984)

Other clearances for product code BZW

  • K874519 — MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR (January 29, 1988)
  • K860558 — ESOPHAGEAL STETHOSCOPE (April 1, 1986)
  • K844444 — ESOPHAGEAL STETHOSCOPE (January 10, 1985)
  • K843070 — ESOPHAGEAL STETHOSCOPES (August 24, 1984)
  • K841574 — QUAZAR 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)

FDA data resources