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510(k) K932712

PRECISION MED PRODUCTS LTD VOLUME VENTILATORS by Precision Med Products, Ltd. — Product Code BZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1993
Date Received
June 4, 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 Precision Med Products, Ltd.

  • K932709 — PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM (July 23, 1993)
  • K932706 — PRECISION MED PRODUCTS LTD. VENTILATOR HOSE (July 23, 1993)
  • K932710 — GAS SAMPLING LINES AND CONNECTORS (July 23, 1993)
  • K932708 — PRECISION MED PRODUCTS LTD MAPLESON D CIRCUITS (July 23, 1993)
  • K932707 — ADULT ANESTHESIA BREATHING CIRCUIT (July 23, 1993)
  • K932711 — PRECISION MED PRODUCTS LTD GUEDEL AIRWAYS (July 23, 1993)
  • K932488 — PMP, LTD. PEDIATRIC GAS SAMPLING CIRCUITS (July 22, 1993)
  • K932489 — PMP, LTD. ADULT TEMP. MONITORING ANESTHESIA CIR. (July 22, 1993)
  • K932497 — PRECISION MED PRODUCTS, LTD. ADULT GAS SAMPLING (July 22, 1993)
  • K932486 — PMP, LTD. PEDIATRIC TEMPERATURE MONITORING CIRCUIT (July 21, 1993)

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)
  • K952022 — PRIMA VOLUMN VENTILATORSS (May 22, 1995)
  • K952011 — PRIMA BREATHING BAGS (May 22, 1995)
  • K952010 — PRIMA VENTILATOR HOSES (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)