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510(k) K931345

CONNECTORS AND AIRWAY EXTENSIONS by Precision Med Products, Ltd. — Product Code BZA

K931345 is an FDA 510(k) premarket notification submitted by Precision Med Products, Ltd. for the device "CONNECTORS AND AIRWAY EXTENSIONS". The FDA issued a decision of Substantially Equivalent on April 23, 1993. The device falls under product code BZA (Connector, Airway (Extension)), a Class I device regulated under 21 CFR 868.5810. Precision Med Products, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1993
Date Received
March 17, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Connector, Airway (Extension)
Device Class
Class I
Regulation Number
868.5810
Review Panel
AN
Submission Type

Other clearances by Precision Med Products, Ltd.

  • K932708 — PRECISION MED PRODUCTS LTD MAPLESON D CIRCUITS (July 23, 1993)
  • K932711 — PRECISION MED PRODUCTS LTD GUEDEL AIRWAYS (July 23, 1993)
  • K932706 — PRECISION MED PRODUCTS LTD. VENTILATOR HOSE (July 23, 1993)
  • K932709 — PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM (July 23, 1993)
  • K932707 — ADULT ANESTHESIA BREATHING CIRCUIT (July 23, 1993)
  • K932710 — GAS SAMPLING LINES AND CONNECTORS (July 23, 1993)
  • K932497 — PRECISION MED PRODUCTS, LTD. ADULT GAS SAMPLING (July 22, 1993)
  • K932489 — PMP, LTD. ADULT TEMP. MONITORING ANESTHESIA CIR. (July 22, 1993)
  • K932712 — PRECISION MED PRODUCTS LTD VOLUME VENTILATORS (July 22, 1993)
  • K932488 — PMP, LTD. PEDIATRIC GAS SAMPLING CIRCUITS (July 22, 1993)

Other clearances for product code BZA

  • K083702 — TRACH-ASSIST (March 5, 2009)
  • K954383 — SURELOC CIRCUIT CONNECTOR (December 22, 1995)
  • K954197 — DISPOSABLE FLEX TUBE (October 26, 1995)
  • K953786 — UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS (September 19, 1995)
  • K952824 — NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR (July 20, 1995)
  • K951345 — DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING (April 14, 1995)
  • K944532 — PRIMA, INC. VENTILATOR HOSES (December 2, 1994)
  • K944535 — PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS (November 29, 1994)
  • K944534 — PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS (November 29, 1994)
  • K942392 — AIRWAY CONNECTOR WITH FLEX TUBE (August 22, 1994)

FDA data resources