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510(k) K830329

ESOPHAGEAL STETHOSCOPE by Science Development Corp. — Product Code BZW

K830329 is an FDA 510(k) premarket notification submitted by Science Development Corp. for the device "ESOPHAGEAL STETHOSCOPE". The FDA issued a decision of Substantially Equivalent on March 11, 1983. The device falls under product code BZW (Stethoscope, Esophageal), a Class I device regulated under 21 CFR 868.1910. Science Development Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1983
Date Received
February 1, 1983
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 Science Development Corp.

  • K843617 — SDC SILICONE SUMP DRAIN (October 24, 1984)
  • K842491 — SDC SILICONE FORCEP SHODS PRODUCT (August 10, 1984)
  • K833355 — SDC VASCULAR TIES (January 27, 1984)
  • K832090 — SCD SKIN TEMP. SENSORS #3400 ETC (October 31, 1983)
  • K832392 — SDC ORAL-RECTAL TEMP. PROBE (September 12, 1983)
  • K832391 — QT-100 ELECTRONIC TEMP. MONITOR (September 12, 1983)
  • K830353 — ESOPHAGEAL PROBE W/TEMP. INDICATOR (April 6, 1983)
  • K830039 — SDC RECTAL TEMP. PROBE PRODUCT #1020 (February 23, 1983)

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)
  • K842865 — ESOPHAGEAL STETHOSCOPE (August 15, 1984)
  • K841574 — QUAZAR ESOPHAGEAL STETHOSCOPE (August 15, 1984)
  • 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