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510(k) K941673

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

K941673 is an FDA 510(k) premarket notification submitted by Polymedica Industries, Inc. for the device "MEDIAID UNIVERSAL THERMOMETER". The FDA issued a decision of Substantially Equivalent on August 25, 1994. The device falls under product code FLK (Thermometer, Clinical Mercury), a Class II device regulated under 21 CFR 880.2920. Polymedica Industries, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Polymedica Industries, Inc.

  • K964398 — SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED (October 24, 1997)
  • K971045 — BASIS FLEXIBLE TIP DIGITAL THERMOMETER (May 2, 1997)
  • K964701 — MITRAFLEX PIGMENTED WOUND DRESSING (February 7, 1997)
  • K963623 — SPYROFLEX PIGMENTED WOUND DRESSING (October 25, 1996)
  • K962991 — BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER (September 12, 1996)
  • K955383 — SPYROCOLLOID WOUND DRESSING (December 13, 1995)
  • K953885 — SPYROFLEX SKIN PROTECTOR (November 29, 1995)
  • K952756 — MEDI-AID BASAL THERMOMETER (September 25, 1995)
  • K952159 — BASIS DIGITAL THERMOMETER (September 22, 1995)
  • K953618 — SPYROFLEX WOUND DRESSING (August 21, 1995)

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)
  • 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