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510(k) K931800

MAG CONNECTORS AND AIRWAY EXTENSIONS by Mag, Inc. — Product Code BZA

K931800 is an FDA 510(k) premarket notification submitted by Mag, Inc. for the device "MAG CONNECTORS AND AIRWAY EXTENSIONS". The FDA issued a decision of Substantially Equivalent on May 19, 1993. The device falls under product code BZA (Connector, Airway (Extension)), a Class I device regulated under 21 CFR 868.5810. Mag, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1993
Date Received
April 12, 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 Mag, Inc.

  • K942132 — M.A.G. INC. HYPERINFLATION SYSTEM (June 22, 1994)
  • K942122 — PEDIATRIC ANESTHESIA CIRCUITS (June 22, 1994)
  • K942127 — M.A.G INC. PEDIATRIC GAS SAMPLING CIRCUITS (June 22, 1994)
  • K942125 — VOLUME VENTILATOR (June 22, 1994)
  • K942123 — M.A.G. INC. VENTILATOR HOSES (June 22, 1994)
  • K942133 — M.A.G. INC. CUSTOM ANESTHESIA CIRCUITS (June 22, 1994)
  • K942136 — M.A.G. INC PEDIATRIC TEMPERATURE MONITORING CIRCUITS (June 22, 1994)
  • K942126 — M.A.G. INC. ADULT ANESTHESIA BREATHING CIRCUIT (June 22, 1994)
  • K942124 — GAS SAMPLING LINES AND CONNECTORS CIRCUITS (June 22, 1994)
  • K942130 — M.A.G. INC. MAPLESON D CIRCUITS (June 22, 1994)

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