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510(k) K952824

NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR by Intertex Medical, Inc. — Product Code BZA

K952824 is an FDA 510(k) premarket notification submitted by Intertex Medical, Inc. for the device "NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR". The FDA issued a decision of Substantially Equivalent on July 20, 1995. The device falls under product code BZA (Connector, Airway (Extension)), a Class I device regulated under 21 CFR 868.5810. Intertex Medical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1995
Date Received
June 20, 1995
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 Intertex Medical, Inc.

  • K830711 — TRACHESTOMY & NASAL SUCTIONING KIT #- (May 2, 1983)

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)
  • 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)
  • K941026 — THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR (August 18, 1994)

FDA data resources