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510(k) K902625

CLINICAL THERMOMETER; RECTAL/ORAL, INNER ARMPIT by Liaoning-Usa Corp. — Product Code FLK

K902625 is an FDA 510(k) premarket notification submitted by Liaoning-Usa Corp. for the device "CLINICAL THERMOMETER; RECTAL/ORAL, INNER ARMPIT". The FDA issued a decision of Substantially Equivalent on October 26, 1990. The device falls under product code FLK (Thermometer, Clinical Mercury), a Class II device regulated under 21 CFR 880.2920. Liaoning-Usa Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1990
Date Received
June 14, 1990
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 Liaoning-Usa Corp.

  • K911921 — DISPOSABLE ISOLATION GOWN (May 13, 1991)
  • K905487 — VARIOUS TYPES OF STETHOSCOPES (April 9, 1991)
  • K910623 — GAUZE SPONGES ABSORBENT GAUZE ROLLS (April 1, 1991)
  • K892781 — ANTELOPE BRAND PATIENT EXAMINATION GLOVES (September 21, 1989)
  • K892774 — PATIENT EXAMINATION GLOVES (September 13, 1989)

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)
  • K913793 — SIMPEX INC. ORAL AND RECTAL THERMOMETERS (December 30, 1991)

FDA data resources