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510(k) K874519

MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR by Mon-A-Therm, Inc. — Product Code BZW

K874519 is an FDA 510(k) premarket notification submitted by Mon-A-Therm, Inc. for the device "MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR". The FDA issued a decision of Substantially Equivalent on January 29, 1988. The device falls under product code BZW (Stethoscope, Esophageal), a Class I device regulated under 21 CFR 868.1910. Mon-A-Therm, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1988
Date Received
November 2, 1987
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 Mon-A-Therm, Inc.

  • K885187 — MODEL 1000 ELECTRONIC CLINICAL THERMOMETER (March 8, 1989)
  • K874522 — MODIFIED MYOCARDIAL TEMPERATURE SENSOR (January 29, 1988)
  • K875234 — MON-A-THERM'S SKIN TEMPERATURE SENSOR (January 19, 1988)
  • K874523 — MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSOR (January 6, 1988)
  • K874524 — MODIFIED SUBCUTANEOUS TEMPERATURE SENSOR (January 6, 1988)
  • K874520 — MODIFIED AIRWAY TEMPERATURE SENSOR (January 6, 1988)
  • K874525 — MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR (January 6, 1988)
  • K874521 — MODIFIED THERMAL WELL TEMPERATURE SENSOR (January 6, 1988)
  • K853392 — MON-A-THERM SUBCUTANEOUS TEMP. SENSOR (November 22, 1985)
  • K830819 — MODIFICATION ELECTRONIC CLINICAL THERMO- (April 6, 1983)

Other clearances for product code BZW

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

FDA data resources