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510(k) K780580

TEMPERATURE INDICATOR by Respiratory Care, Inc. — Product Code KPD

K780580 is an FDA 510(k) premarket notification submitted by Respiratory Care, Inc. for the device "TEMPERATURE INDICATOR". The FDA issued a decision of Substantially Equivalent on Apr 27, 1978. The device falls under product code KPD (Strip, Temperature, Forehead, Liquid Crystal), a Class II device regulated under 21 CFR 880.2200. Respiratory Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 27, 1978
Date Received
Apr 10, 1978
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 Respiratory Care, Inc.

  • K892230 — RCI VIRAL/BACTERIAL FILTER (Aug 28, 1989)
  • K884150 — MODIFIED CONCHATHERM III CONTROLLED HEATER (Nov 21, 1988)
  • K881625 — CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL (Jun 21, 1988)
  • K864147 — AQUAVALVE (Dec 5, 1986)
  • K863955 — COLBY LEVEL ALARM (Nov 7, 1986)
  • K861555 — CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT (Jun 5, 1986)
  • K834151 — CONCHATHERM LHF HUMIDIFIER HEATER (Jan 13, 1984)
  • K833974 — AQUAPAK 020 HUMIDIFIER ADAPTER (Dec 16, 1983)
  • K832453 — SLIMB SINGLE LIMB BREATHING CIRCUIT (Oct 27, 1983)
  • K811524 — AQUACADE (Jul 1, 1981)

Other clearances for product code KPD

  • K934941 — E-Z TEMP II (Jul 27, 1994)
  • K903307 — TEMP MARQ TEMPERATURE TREND INDICATOR (Aug 17, 1990)
  • K893803 — FEVER LINE AND FEVER LINE PLUS (Aug 21, 1989)
  • K864853 — OMNI THERM TEMPERATURE MONITOR (Feb 4, 1987)
  • K850797 — TEMPALERT LIQUID CRYSTAL THERMOMETER (Apr 5, 1985)
  • K841913 — TEMPTREND PEDS AXILLARY TEMP. INDICATOR (Nov 2, 1984)
  • K833904 — TEMPTREND II (Dec 27, 1983)
  • K832651 — ATI FOREHEAD THERMOMETER (Oct 4, 1983)
  • K823221 — ACCA-TEMP SKIN TEMP. VINYL DISC (Jan 12, 1983)
  • K821312 — TEMPTREND TEMPERATURE TREND INDICATOR (May 28, 1982)

FDA data resources