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510(k) K960185

AMSINO CLINICAL THERMOMETER by Amsia Intl., Inc. — Product Code FLK

K960185 is an FDA 510(k) premarket notification submitted by Amsia Intl., Inc. for the device "AMSINO CLINICAL THERMOMETER". The FDA issued a decision of Substantially Equivalent on March 28, 1996. The device falls under product code FLK (Thermometer, Clinical Mercury), a Class II device regulated under 21 CFR 880.2920. Amsia Intl., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1996
Date Received
January 16, 1996
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 Amsia Intl., Inc.

  • K891866 — RUBBER LATEX PATIENT EXAMINATION GLOVES (April 11, 1989)

Other clearances for product code FLK

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

FDA data resources