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510(k) K890011

OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING by Life Design Systems, Inc. — Product Code BZO

K890011 is an FDA 510(k) premarket notification submitted by Life Design Systems, Inc. for the device "OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING". The FDA issued a decision of Substantially Equivalent on March 20, 1989. The device falls under product code BZO (Set, Tubing And Support, Ventilator (W Harness)), a Class I device regulated under 21 CFR 868.5975. Life Design Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1989
Date Received
January 3, 1989
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 Life Design Systems, Inc.

  • K913714 — MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM) (December 1, 1992)
  • K885313 — HUMIDI-FLEX TM (October 11, 1989)
  • K893030 — CHILD SIZE - FILTER FLEX (TM) (September 18, 1989)
  • K892862 — FLEX-CUP PERCUSSOR (May 25, 1989)
  • K892221 — PULMONARY RESUSCITATOR, MODIFICATION (May 18, 1989)
  • K890108 — MODIFIED CUSHION-FLEX(TM) (January 24, 1989)
  • K884387 — CUSHION FLEX(TM) (November 17, 1988)
  • K884068 — PULMANEX TM (NEO-NATAL SIZE) (November 16, 1988)
  • K873179 — HEATER WIRE BREATHING CIRCUIT (March 31, 1988)
  • K863857 — PULSE-OX (October 7, 1987)

Other clearances for product code BZO

  • K953784 — UNICOR, INC. CORRUGATED TUBING (September 19, 1995)
  • K953785 — UNICOR, INC. VENTILATOR HOSES (September 18, 1995)
  • K952012 — PRIMA CUSTOM ANESTESIA CIRCUIT (May 22, 1995)
  • K952010 — PRIMA VENTILATOR HOSES (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)
  • K942569 — VENTILATOR HOSE (June 10, 1994)
  • K942572 — VOLUME VENTILATOR (June 10, 1994)

FDA data resources