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510(k) K792426

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

K792426 is an FDA 510(k) premarket notification submitted by Hospitak, Inc. for the device "DISPOSABLE TEMPERATURE PROBE". The FDA issued a decision of Substantially Equivalent on January 16, 1980. The device falls under product code FLK (Thermometer, Clinical Mercury), a Class II device regulated under 21 CFR 880.2920. Hospitak, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Hospitak, Inc.

  • K955483 — TRACH MASK MODEL (245, 246) (February 28, 1996)
  • K954787 — ILLUMINATOR (January 31, 1996)
  • K953620 — WARM N WET HMEF W/LUER ADAPTER (August 25, 1995)
  • K953619 — WARM N WET HME W/LUER ADAPTER (August 25, 1995)
  • K915750 — DISPOSABLE BACTERIAL BREATHNG FILTER (November 30, 1994)
  • K920842 — AEROSOL DELIVERY SYSTEMS (May 15, 1992)
  • K915228 — DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNUL (February 11, 1992)
  • K873286 — DISPOSABLE, MANUAL PULMONARY RESUSCITATOR (October 26, 1987)
  • K853600 — INFLATABLE AIR SPLINTS (September 19, 1985)
  • K844328 — OXYGEN CONCENTRATOR (December 4, 1984)

Other clearances for product code FLK

  • K960185 — AMSINO CLINICAL THERMOMETER (March 28, 1996)
  • K960224 — GERATHERM MERCUIRY FREE CLINICAL THERMOMETER (March 25, 1996)
  • K953465 — KENTEMP (December 15, 1995)
  • K942483 — CLINICAL GLASS THERMOMETER (March 28, 1995)
  • K941673 — MEDIAID UNIVERSAL THERMOMETER (August 25, 1994)
  • K940394 — AMG MED BRAND CLINICAL GLASS THERMOMETER (May 4, 1994)
  • K940380 — 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)

FDA data resources