Home / 510(k) Clearances / K863910

510(k) K863910

RAINCOAT by Artec Environmental Monitoring Division — Product Code BZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1986
Date Received
October 8, 1986
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 Artec Environmental Monitoring Division

  • K900839 — THE CAROLINA ROCKER (April 18, 1990)
  • K896886 — ARTEC RESPOND PULMONARY RESUSCITATOR (February 6, 1990)
  • K873043 — MOUTH TO FACE RESUSCITATOR (September 28, 1987)
  • K854573 — ANESTHESIA SHUTOFF VALVE POSITIVE CLOSURE (January 3, 1986)
  • K832512 — AIRWAY MASKS (January 17, 1984)
  • K830056 — ARTEC TWIST VALVE (March 9, 1983)

Other clearances for product code BZO

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