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510(k) K823126

MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER by Electromedics, Inc. — Product Code BZW

K823126 is an FDA 510(k) premarket notification submitted by Electromedics, Inc. for the device "MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER". The FDA issued a decision of Substantially Equivalent on November 16, 1982. The device falls under product code BZW (Stethoscope, Esophageal), a Class I device regulated under 21 CFR 868.1910. Electromedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1982
Date Received
October 25, 1982
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 Electromedics, Inc.

  • K934964 — ELECTROMEDICS TYMPANIC TEMPERATURE SENSOR (March 7, 1994)
  • K933832 — ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSOR (January 28, 1994)
  • K934355 — ELECTROMEDICS BLOOD HEAT EXCHANGER (December 3, 1993)
  • K930154 — EL2-SERIES BLOOD COLLECTION REERVOIR (July 1, 1993)
  • K926250 — ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR (February 19, 1993)
  • K925412 — ELECTROMEDICS TISSUE TRAP/ #TT280 (February 5, 1993)
  • K915737 — AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR (September 3, 1992)
  • K910238 — PORTABLE AUTO TRANSFUSION SYSTEM 500 (June 19, 1991)
  • K910935 — MODIFIED PYROGEN TESTING (May 16, 1991)
  • K902723 — ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20 (December 13, 1990)

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)
  • K800463 — ESOPHAGEAL STETHESCOPE (March 10, 1980)

FDA data resources