CN Endotracheal Tube Holder

FDA 510(k) K921698 · N-C-N Products Co.

Substantially Equivalent

510(k) numberK921698

Submission

Device name
CN Endotracheal Tube Holder
Applicant
N-C-N Products Co.
Barrington, IL, US
Received
April 8, 1992
Decision date
September 15, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
CBH – Device, Fixation, Tracheal Tube
Device class
Class I (low risk)
Regulation
21 CFR 868.5770
Specialty
Anesthesiology

Other 510(k)s with product code CBH

510(k)DeviceApplicantDecision
K140097Amt Endotracheal Tube Bridle Retention SystemCBH · Traditional Applied Medical Technology, Inc.09/24/2014SE
K964399Dale Endotracheal Tube Holder 270/280CBH · Traditional Dale Medical Products, Inc.01/28/1997SE
K942529Hci Tube StabilizerCBH · Traditional Health Care Contracts, Inc.06/14/1995SE
K951491Dale Tracheostomy Tube Holder with Trach Mask Attachment TabsCBH · Traditional Dale Medical Products, Inc.04/24/1995SE
K950930Trache-TiteCBH · Traditional The Varner Group, Inc.03/22/1995SE
K950318Flex BlueCBH · Traditional King Systems Corp.02/13/1995SE
K942395Endotracheal Tube HolderCBH · Traditional S.T.I. Medical Products Corp.06/30/1994SE
K934288Holde.T. Endotracheal Tube Stabilization BarCBH · Traditional Neo-Tech, Inc.06/09/1994SE
K942016Trach Tie, Ventilator Tubing HolderCBH · Traditional Garrett Medical Products05/24/1994SE
K941384TrakeezCBH · Traditional Ergomed, Inc.04/19/1994SE

Questions and answers

When was CN Endotracheal Tube Holder cleared by the FDA?

CN Endotracheal Tube Holder (K921698) received a 510(k) decision of Substantially Equivalent on September 15, 1992, 160 days after the submission was received.

What is the product code of K921698?

The FDA product code is CBH – Device, Fixation, Tracheal Tube, a Class I (low risk) device regulated under 21 CFR 868.5770.