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510(k) K790532

FEVER TESTER by Maddak, Inc. — Product Code KPD

K790532 is an FDA 510(k) premarket notification submitted by Maddak, Inc. for the device "FEVER TESTER". The FDA issued a decision of Substantially Equivalent on May 29, 1979. The device falls under product code KPD (Strip, Temperature, Forehead, Liquid Crystal), a Class II device regulated under 21 CFR 880.2200. Maddak, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1979
Date Received
March 15, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Strip, Temperature, Forehead, Liquid Crystal
Device Class
Class II
Regulation Number
880.2200
Review Panel
HO
Submission Type

Other clearances by Maddak, Inc.

  • K841700 — WALK & ROLL (May 11, 1984)
  • K841695 — CRAWLER (May 10, 1984)
  • K841698 — HEAT PACK (May 10, 1984)
  • K841693 — STANDING FRAME (May 9, 1984)
  • K841697 — HYDRO-THERO PAD (May 9, 1984)
  • K841691 — SPLIT SEAT POSITIONING CHAIR (May 9, 1984)
  • K841692 — PRONE STANDER (May 9, 1984)
  • K834311 — NIGHT TRAINER (March 30, 1984)
  • K833870 — KNEE WALKER (November 29, 1983)
  • K833177 — GLOSSECTOMY FEEDING SPOONS (October 31, 1983)

Other clearances for product code KPD

  • K934941 — E-Z TEMP II (July 27, 1994)
  • K903307 — TEMP MARQ TEMPERATURE TREND INDICATOR (August 17, 1990)
  • K893803 — FEVER LINE AND FEVER LINE PLUS (August 21, 1989)
  • K864853 — OMNI THERM TEMPERATURE MONITOR (February 4, 1987)
  • K850797 — TEMPALERT LIQUID CRYSTAL THERMOMETER (April 5, 1985)
  • K841913 — TEMPTREND PEDS AXILLARY TEMP. INDICATOR (November 2, 1984)
  • K833904 — TEMPTREND II (December 27, 1983)
  • K832651 — ATI FOREHEAD THERMOMETER (October 4, 1983)
  • K823221 — ACCA-TEMP SKIN TEMP. VINYL DISC (January 12, 1983)
  • K821312 — TEMPTREND TEMPERATURE TREND INDICATOR (May 28, 1982)

FDA data resources