Home / 510(k) Clearances / K882203

510(k) K882203

NEOTECH UNIVERSAL ADAPTER by Neotech Products, Inc. — Product Code BZA

K882203 is an FDA 510(k) premarket notification submitted by Neotech Products, Inc. for the device "NEOTECH UNIVERSAL ADAPTER". The FDA issued a decision of Substantially Equivalent on June 17, 1988. The device falls under product code BZA (Connector, Airway (Extension)), a Class I device regulated under 21 CFR 868.5810. Neotech Products, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1988
Date Received
May 25, 1988
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 Neotech Products, Inc.

  • K011564 — NEOLEAD (January 3, 2002)
  • K931727 — URINARY DRAINAGE BAG CADDY (July 23, 1993)
  • K921024 — URO-TOTE LEG BAG (September 2, 1992)
  • K890425 — NEOTECH MUCUS TRAP W/CATHETER (April 19, 1989)
  • K880487 — NEOTECH MECONIUM ASPIRATOR (STERILE) (May 6, 1988)

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