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510(k) K930929

ESOPHAGEAL STETHOSCOPE by Coast Medical Corp. — Product Code BZT

K930929 is an FDA 510(k) premarket notification submitted by Coast Medical Corp. for the device "ESOPHAGEAL STETHOSCOPE". The FDA issued a decision of Substantially Equivalent on March 17, 1995. The device falls under product code BZT (Stethoscope, Esophageal, With Electrical Conductors), a Class II device regulated under 21 CFR 868.1920. Coast Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1995
Date Received
February 23, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stethoscope, Esophageal, With Electrical Conductors
Device Class
Class II
Regulation Number
868.1920
Review Panel
AN
Submission Type

Other clearances by Coast Medical Corp.

  • K952243 — EXTENSION SET/I.V. SET (July 26, 1995)
  • K944729 — STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE (December 21, 1994)
  • K943270 — SURFACE TEMPERATURE PROBES (December 5, 1994)
  • K943495 — DISPOSABLE ESOPHAGEAL STETHOSCOPE (September 8, 1994)
  • K943110 — GAS SAMPLING INTERFACES (August 19, 1994)
  • K930930 — COAST MEDICAL, INC. RECTAL PROBE (February 25, 1994)
  • K925781 — DISPOSABLE CUFFED ENDOTRACHEAL TUBE (April 19, 1993)
  • K925855 — DISPOSABLE UNCUFFED ENDOTRACHEAL TUBE (February 18, 1993)
  • K921077 — DISPOSABLE INTUBATION KITS (August 25, 1992)
  • K921353 — NASOPHARYNGEAL AIRWAY (June 11, 1992)

Other clearances for product code BZT

  • K251025 — Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, (December 29, 2025)
  • K193027 — Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal St (April 2, 2020)
  • K140134 — ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSC (June 16, 2014)
  • K111050 — ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TE (April 12, 2012)
  • K092716 — ESOPHAGEAL STETHOSCOPE (September 17, 2009)
  • K072621 — ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE (December 13, 2007)
  • K062020 — LIFESOUND ESOPHAGEAL STETHOSCOPE (September 5, 2006)
  • K982193 — ESOPHAGEAL STETHOSCOPE (September 1, 1998)
  • K973839 — DISPOSABLE ESOPHAGEAL STETHOSCOPE (March 19, 1998)
  • K961060 — ARISTO ESOPHAGEAL STETHOSCOPE (June 19, 1996)

FDA data resources