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510(k) K863987

BI-TEMP TEMPERATURE MONITOR by Respiratory Support Products, Inc.

K863987 is an FDA 510(k) premarket notification submitted by Respiratory Support Products, Inc. for the device "BI-TEMP TEMPERATURE MONITOR". The FDA issued a decision of Substantially Equivalent on November 18, 1986. Respiratory Support Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1986
Date Received
October 14, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Respiratory Support Products, Inc.

  • K983862 — CLOUD 1 HUMIDIFICATION SYSTEM (May 24, 1999)
  • K921190 — ADAP-TEMP TEMPERATURE SENSOR ADAPTER (March 9, 1993)
  • K920469 — MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE (September 11, 1992)
  • K921510 — GAS SAMPLING KIT MODIFICATION (June 11, 1992)
  • K913082 — BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D (December 11, 1991)
  • K913083 — BI-TEMP TEMPERATURE MONITOR TM-201D (October 17, 1991)
  • K912280 — BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D (October 17, 1991)
  • K903816 — URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR (October 31, 1990)
  • K874694 — ADAP-TEMP, MODEL: AT-100 (March 1, 1988)
  • K873472 — MEMBRANE HUMIDIFIER (January 19, 1988)

FDA data resources