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510(k) K932706

PRECISION MED PRODUCTS LTD. VENTILATOR HOSE by Precision Med Products, Ltd. — Product Code BZO

K932706 is an FDA 510(k) premarket notification submitted by Precision Med Products, Ltd. for the device "PRECISION MED PRODUCTS LTD. VENTILATOR HOSE". The FDA issued a decision of Substantially Equivalent on July 23, 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. Precision Med Products, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 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.

  • K932710 — GAS SAMPLING LINES AND CONNECTORS (July 23, 1993)
  • K932709 — PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM (July 23, 1993)
  • K932707 — ADULT ANESTHESIA BREATHING CIRCUIT (July 23, 1993)
  • K932708 — PRECISION MED PRODUCTS LTD MAPLESON D CIRCUITS (July 23, 1993)
  • K932711 — PRECISION MED PRODUCTS LTD GUEDEL AIRWAYS (July 23, 1993)
  • K932489 — PMP, LTD. ADULT TEMP. MONITORING ANESTHESIA CIR. (July 22, 1993)
  • K932497 — PRECISION MED PRODUCTS, LTD. ADULT GAS SAMPLING (July 22, 1993)
  • K932488 — PMP, LTD. PEDIATRIC GAS SAMPLING CIRCUITS (July 22, 1993)
  • K932712 — PRECISION MED PRODUCTS LTD VOLUME VENTILATORS (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)
  • 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