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510(k) K874525

MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR by Mon-A-Therm, Inc. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1988
Date Received
November 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
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)
  • K874522 — MODIFIED MYOCARDIAL TEMPERATURE SENSOR (January 29, 1988)
  • K875234 — MON-A-THERM'S SKIN TEMPERATURE SENSOR (January 19, 1988)
  • K874520 — MODIFIED AIRWAY TEMPERATURE SENSOR (January 6, 1988)
  • K874521 — MODIFIED THERMAL WELL TEMPERATURE SENSOR (January 6, 1988)
  • K874523 — MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. 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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