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510(k) K913793

SIMPEX INC. ORAL AND RECTAL THERMOMETERS by Simpex, Inc. — Product Code FLK

K913793 is an FDA 510(k) premarket notification submitted by Simpex, Inc. for the device "SIMPEX INC. ORAL AND RECTAL THERMOMETERS". The FDA issued a decision of Substantially Equivalent on December 30, 1991. The device falls under product code FLK (Thermometer, Clinical Mercury), a Class II device regulated under 21 CFR 880.2920. Simpex, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1991
Date Received
August 23, 1991
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 Simpex, Inc.

  • K920174 — EASY TOUCH LATEX EAM GLOVES (April 22, 1992)
  • K913794 — SIMPEX INC. SURGICAL DRESSING (November 20, 1991)
  • K911505 — FIXATION WIRE (April 12, 1991)
  • K911452 — FIXATION PIN (April 12, 1991)

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)
  • 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)
  • K911269 — MERCURY AND GLASS FEVER THERMOMETER (May 15, 1991)

FDA data resources