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510(k) K863910

RAINCOAT by Artec Environmental Monitoring Division — Product Code BZO

K863910 is an FDA 510(k) premarket notification submitted by Artec Environmental Monitoring Division for the device "RAINCOAT". The FDA issued a decision of Substantially Equivalent on October 20, 1986. The device falls under product code BZO (Set, Tubing And Support, Ventilator (W Harness)), a Class I device regulated under 21 CFR 868.5975. Artec Environmental Monitoring Division has at least 6 other 510(k) clearances on record.

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)
  • K952022 — PRIMA VOLUMN VENTILATORSS (May 22, 1995)
  • K952010 — PRIMA VENTILATOR HOSES (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)
  • K942572 — VOLUME VENTILATOR (June 10, 1994)
  • K942569 — VENTILATOR HOSE (June 10, 1994)

FDA data resources