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510(k) K941673

MEDIAID UNIVERSAL THERMOMETER by Polymedica Industries, Inc. — Product Code FLK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1994
Date Received
April 5, 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

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  • K942483 — CLINICAL GLASS THERMOMETER (March 28, 1995)
  • 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)