Hci Tube Stabilizer

FDA 510(k) K942529 · Health Care Contracts, Inc.

Substantially Equivalent

510(k) numberK942529

Submission

Device name
Hci Tube Stabilizer
Applicant
Health Care Contracts, Inc.
San Antonio, TX, US
Received
May 27, 1994
Decision date
June 14, 1995
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
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
K940448Netoh Endotracheal Tube HolderCBH · Traditional Medical Accessory Services, Inc.02/22/1994SE

Questions and answers

When was Hci Tube Stabilizer cleared by the FDA?

Hci Tube Stabilizer (K942529) received a 510(k) decision of Substantially Equivalent on June 14, 1995, 383 days after the submission was received.

What is the product code of K942529?

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