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510(k) K873696

BODAI NEO2-SAFE(TM) by B&B Medical Technologies, Inc. — Product Code BZA

K873696 is an FDA 510(k) premarket notification submitted by B&B Medical Technologies, Inc. for the device "BODAI NEO2-SAFE(TM)". The FDA issued a decision of Substantially Equivalent on April 14, 1988. The device falls under product code BZA (Connector, Airway (Extension)), a Class I device regulated under 21 CFR 868.5810. B&B Medical Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1988
Date Received
September 14, 1987
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 B&B Medical Technologies, Inc.

  • K030396 — OMNI~NEB; OMNI~MAX (May 7, 2004)
  • K980407 — HOPE NEBULIZER (May 27, 1998)
  • K960663 — UNIVERSAL BITE BLOCK (May 17, 1996)
  • K945816 — QUICK-LOCK (January 13, 1995)
  • K944324 — SURE-LOCK VENTILATOR TUBING HOLDER (November 4, 1994)
  • K935171 — STABILTRACH (December 2, 1993)
  • K925386 — ADHESIVE E.T. TAPE (April 19, 1993)
  • K923690 — MINI HEART (October 20, 1992)
  • K913015 — HEART NEBULIZER FLOWMETER ADAPTOR (November 20, 1991)
  • K913753 — BODAI NEO2 -SAFE AIRWAY PRESSURE CAP (October 23, 1991)

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