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510(k) K911269

MERCURY AND GLASS FEVER THERMOMETER by Steridyne Corp. — Product Code FLK

K911269 is an FDA 510(k) premarket notification submitted by Steridyne Corp. for the device "MERCURY AND GLASS FEVER THERMOMETER". The FDA issued a decision of Substantially Equivalent on May 15, 1991. The device falls under product code FLK (Thermometer, Clinical Mercury), a Class II device regulated under 21 CFR 880.2920. Steridyne Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1991
Date Received
March 22, 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 Steridyne Corp.

  • K925352 — CLEAN CUFF BLOOD PRESSURE CUFF LINER (January 12, 1993)
  • K911843 — ZERO-G(TM) GEL/FOAM MATTRESS TOPPER (May 30, 1991)
  • K842120 — ZERO-G (June 8, 1984)
  • K821314 — FEVER METER (May 28, 1982)
  • K801458 — WINTER HEAD DRESSING (July 28, 1980)

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