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510(k) K900912

BABY E.T. TAPE II by B&B Medical Technologies, Inc. — Product Code CBH

K900912 is an FDA 510(k) premarket notification submitted by B&B Medical Technologies, Inc. for the device "BABY E.T. TAPE II". The FDA issued a decision of Substantially Equivalent on August 3, 1990. The device falls under product code CBH (Device, Fixation, Tracheal Tube), a Class I device regulated under 21 CFR 868.5770. B&B Medical Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1990
Date Received
February 27, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Fixation, Tracheal Tube
Device Class
Class I
Regulation Number
868.5770
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 CBH

  • K140097 — AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM (September 24, 2014)
  • K964399 — DALE ENDOTRACHEAL TUBE HOLDER 270/280 (January 28, 1997)
  • K942529 — HCI TUBE STABILIZER (June 14, 1995)
  • K951491 — DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS (April 24, 1995)
  • K950930 — TRACHE-TITE (March 22, 1995)
  • K950318 — FLEX BLUE (February 13, 1995)
  • K942395 — ENDOTRACHEAL TUBE HOLDER (June 30, 1994)
  • K934288 — HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BAR (June 9, 1994)
  • K942016 — TRACH TIE, VENTILATOR TUBING HOLDER (May 24, 1994)
  • K941384 — TRAKEEZ (April 19, 1994)

FDA data resources