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510(k) K790523

ARGYLE ESOPHAGEAL STETHOSCOPE by Sherwood Medical Industries — Product Code BZW

K790523 is an FDA 510(k) premarket notification submitted by Sherwood Medical Industries for the device "ARGYLE ESOPHAGEAL STETHOSCOPE". The FDA issued a decision of Substantially Equivalent on March 27, 1979. The device falls under product code BZW (Stethoscope, Esophageal), a Class I device regulated under 21 CFR 868.1910. Sherwood Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1979
Date Received
March 15, 1979
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 Sherwood Medical Industries

  • K801070 — SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES (July 21, 1980)
  • K801071 — LANCER GLUCOSE RATE REAGENT KIT (May 23, 1980)
  • K792014 — LANCER L-INA BUFFER, POLYMER, WASH SOLU (November 13, 1979)
  • K792013 — LANCER L-INA HUMAN REFERENCE SERUM (November 13, 1979)
  • K782077 — LANCER ICE CUBE (April 3, 1979)
  • K790196 — MONOJECT ARTERIAL BLOOD SAMPLING DEVICE (March 13, 1979)
  • K790197 — REAGENT KIT, LANCER GLUCOSE (March 12, 1979)
  • K781459 — MONOJECT SCALE MAGNIFIER (October 24, 1978)
  • K781060 — MONOJECT ENDOSSEOUS DENTAL IMPLANT (August 14, 1978)
  • K772149 — LANCER BIOPSY HOLDER (November 22, 1977)

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)
  • 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)

FDA data resources