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510(k) K934941

E-Z TEMP II by Seven C'S, Inc. — Product Code KPD

K934941 is an FDA 510(k) premarket notification submitted by Seven C'S, Inc. for the device "E-Z TEMP II". The FDA issued a decision of Substantially Equivalent on July 27, 1994. The device falls under product code KPD (Strip, Temperature, Forehead, Liquid Crystal), a Class II device regulated under 21 CFR 880.2200.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1994
Date Received
October 18, 1993
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 for product code KPD

  • 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)
  • K820426 — TEMPERATURE TREND INDICATOR (TTI) (March 8, 1982)

FDA data resources