Home / 510(k) Clearances / K921510

510(k) K921510

GAS SAMPLING KIT MODIFICATION by Respiratory Support Products, Inc. — Product Code BZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1992
Date Received
March 13, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Tubing And Support, Ventilator (W Harness)
Device Class
Class I
Regulation Number
868.5975
Review Panel
AN
Submission Type

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)
  • 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)
  • K873205 — TYMPANIC TEMPERATURE SENSOR (January 14, 1988)

Other clearances for product code BZO

  • K953784 — UNICOR, INC. CORRUGATED TUBING (September 19, 1995)
  • K953785 — UNICOR, INC. VENTILATOR HOSES (September 18, 1995)
  • K952010 — PRIMA VENTILATOR HOSES (May 22, 1995)
  • K952012 — PRIMA CUSTOM ANESTESIA CIRCUIT (May 22, 1995)
  • K952022 — PRIMA VOLUMN VENTILATORSS (May 22, 1995)
  • K952011 — PRIMA BREATHING BAGS (May 22, 1995)
  • K945740 — INFANT FLOW SYSTEM (March 23, 1995)
  • K944531 — PRIMA, INC. CORRUGATED TUBING (December 2, 1994)
  • K942572 — VOLUME VENTILATOR (June 10, 1994)
  • K942569 — VENTILATOR HOSE (June 10, 1994)