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510(k) K792426

DISPOSABLE TEMPERATURE PROBE by Hospitak, Inc. — Product Code FLK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1980
Date Received
November 28, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thermometer, Clinical Mercury
Device Class
Class II
Regulation Number
880.2920
Review Panel
HO
Submission Type

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  • K873286 — DISPOSABLE, MANUAL PULMONARY RESUSCITATOR (October 26, 1987)
  • K853600 — INFLATABLE AIR SPLINTS (September 19, 1985)
  • K844328 — OXYGEN CONCENTRATOR (December 4, 1984)

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  • K953465 — KENTEMP (December 15, 1995)
  • K942483 — CLINICAL GLASS THERMOMETER (March 28, 1995)
  • K941673 — MEDIAID UNIVERSAL THERMOMETER (August 25, 1994)
  • K940380 — AMG MED BRAND CLINICAL GLASS THERMOMETER (May 4, 1994)
  • K940394 — AMG MED BRAND CLINICAL GLASS THERMOMETER (May 4, 1994)
  • K932991 — GUARDIAN AND ANDINO MODELS (January 28, 1994)
  • K923225 — LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOME (June 8, 1993)
  • K913793 — SIMPEX INC. ORAL AND RECTAL THERMOMETERS (December 30, 1991)