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510(k) K844444

ESOPHAGEAL STETHOSCOPE by Medical Parameters, Inc. — Product Code BZW

K844444 is an FDA 510(k) premarket notification submitted by Medical Parameters, Inc. for the device "ESOPHAGEAL STETHOSCOPE". The FDA issued a decision of Substantially Equivalent on January 10, 1985. The device falls under product code BZW (Stethoscope, Esophageal), a Class I device regulated under 21 CFR 868.1910. Medical Parameters, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1985
Date Received
November 16, 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 Medical Parameters, Inc.

  • K862190 — WALRUS: DOUBLE BALLOON SHUNTING CATHETER (November 3, 1986)
  • K833825 — MULTI-LUMEN INTRAVENOUS INFUSION CATH (January 10, 1984)
  • K830754 — BLOOD PRESSURE MONITORING KITS,WALRUS (August 12, 1983)
  • K831239 — WALRUS PERCUTANEOUS INTRODUCER SET (May 25, 1983)
  • K830755 — I.V. SETS WALRUS BRAND VARIOUS CONFIGUR- (April 28, 1983)

Other clearances for product code BZW

  • K874519 — MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR (January 29, 1988)
  • K860558 — ESOPHAGEAL STETHOSCOPE (April 1, 1986)
  • K843070 — ESOPHAGEAL STETHOSCOPES (August 24, 1984)
  • K842865 — ESOPHAGEAL STETHOSCOPE (August 15, 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