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510(k) K953465

KENTEMP by Kentron Health Care, Inc. — Product Code FLK

K953465 is an FDA 510(k) premarket notification submitted by Kentron Health Care, Inc. for the device "KENTEMP". The FDA issued a decision of Substantially Equivalent on December 15, 1995. The device falls under product code FLK (Thermometer, Clinical Mercury), a Class II device regulated under 21 CFR 880.2920. Kentron Health Care, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1995
Date Received
July 24, 1995
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 Kentron Health Care, Inc.

  • K030693 — KENTEX DISPOSABLE VAGINAL SPECULUM (August 27, 2003)
  • K971917 — KENTRON'S ISOLATION GOWN (September 19, 1997)
  • K972410 — IMPERVIOUS ISOLATION GOWN (September 19, 1997)
  • K953914 — KENTEX (November 6, 1995)
  • K953830 — KENSORB (October 3, 1995)

Other clearances for product code FLK

  • K960185 — AMSINO CLINICAL THERMOMETER (March 28, 1996)
  • K960224 — GERATHERM MERCUIRY FREE CLINICAL THERMOMETER (March 25, 1996)
  • 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)
  • K911269 — MERCURY AND GLASS FEVER THERMOMETER (May 15, 1991)

FDA data resources