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510(k) K932563

VENTILATOR HOSES by Life Shield Healthcare Products, Inc. — Product Code BZO

K932563 is an FDA 510(k) premarket notification submitted by Life Shield Healthcare Products, Inc. for the device "VENTILATOR HOSES". The FDA issued a decision of Substantially Equivalent on July 16, 1993. 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 Shield Healthcare Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1993
Date Received
May 27, 1993
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 Shield Healthcare Products, Inc.

  • K932562 — GAS SAMPLING LINES AND CONNECTORS (July 23, 1993)
  • K932560 — VOLUME VENTILATORS (July 22, 1993)
  • K932558 — ADULT ANESTHESIA BREATHING CIRCUIT (July 22, 1993)
  • K932557 — HYPERINFLATION SYSTEM (July 22, 1993)
  • K932561 — GUEDEL AIRWAYS (July 22, 1993)
  • K932559 — MAPLESON D CIRCUITS (July 16, 1993)
  • K932193 — PEDIATRIC TEMPERATURE MONITORING CIRCUITS (July 2, 1993)
  • K932194 — PEDIATRIC GASSAMPLING CIRCUITS (July 2, 1993)
  • K932191 — BREATHING BAGS (July 2, 1993)
  • K932195 — ADULT GAS SAMPLING CIRCUITS (July 2, 1993)

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