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510(k) K874522

MODIFIED MYOCARDIAL TEMPERATURE SENSOR by Mon-A-Therm, Inc. — Product Code KRB

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
Probe, Thermodilution
Device Class
Class II
Regulation Number
870.1915
Review Panel
CV
Submission Type

Other clearances by Mon-A-Therm, Inc.

  • K885187 — MODEL 1000 ELECTRONIC CLINICAL THERMOMETER (March 8, 1989)
  • K874519 — MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR (January 29, 1988)
  • K875234 — MON-A-THERM'S SKIN TEMPERATURE SENSOR (January 19, 1988)
  • K874521 — MODIFIED THERMAL WELL TEMPERATURE SENSOR (January 6, 1988)
  • K874523 — MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSOR (January 6, 1988)
  • K874520 — MODIFIED AIRWAY TEMPERATURE SENSOR (January 6, 1988)
  • K874525 — MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR (January 6, 1988)
  • K874524 — MODIFIED SUBCUTANEOUS TEMPERATURE SENSOR (January 6, 1988)
  • K853392 — MON-A-THERM SUBCUTANEOUS TEMP. SENSOR (November 22, 1985)
  • K830819 — MODIFICATION ELECTRONIC CLINICAL THERMO- (April 6, 1983)

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