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510(k) K841913

TEMPTREND PEDS AXILLARY TEMP. INDICATOR by Biosynergy, Inc. — Product Code KPD

K841913 is an FDA 510(k) premarket notification submitted by Biosynergy, Inc. for the device "TEMPTREND PEDS AXILLARY TEMP. INDICATOR". The FDA issued a decision of Substantially Equivalent on November 2, 1984. The device falls under product code KPD (Strip, Temperature, Forehead, Liquid Crystal), a Class II device regulated under 21 CFR 880.2200. Biosynergy, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1984
Date Received
May 9, 1984
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 Biosynergy, Inc.

  • K833904 — TEMPTREND II (December 27, 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)
  • 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