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510(k) K942483

CLINICAL GLASS THERMOMETER by Makol Medical Instruments Corp. — Product Code FLK

K942483 is an FDA 510(k) premarket notification submitted by Makol Medical Instruments Corp. for the device "CLINICAL GLASS THERMOMETER". The FDA issued a decision of Substantially Equivalent on March 28, 1995. The device falls under product code FLK (Thermometer, Clinical Mercury), a Class II device regulated under 21 CFR 880.2920.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1995
Date Received
May 25, 1994
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 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)
  • 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)
  • K911269 — MERCURY AND GLASS FEVER THERMOMETER (May 15, 1991)

FDA data resources