Endotracheal Tube Holder
FDA 510(k) K802601 · Hudson Oxygen Therapy Sales Co.
510(k) numberK802601
Submission
- Device name
- Endotracheal Tube Holder
- Applicant
- Hudson Oxygen Therapy Sales Co.
Mchenry, IL, US - Received
- October 21, 1980
- Decision date
- December 18, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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) | Device | Applicant | Decision |
|---|---|---|---|
| K140097 | Amt Endotracheal Tube Bridle Retention SystemCBH · Traditional | Applied Medical Technology, Inc. | 09/24/2014SE |
| K964399 | Dale Endotracheal Tube Holder 270/280CBH · Traditional | Dale Medical Products, Inc. | 01/28/1997SE |
| K942529 | Hci Tube StabilizerCBH · Traditional | Health Care Contracts, Inc. | 06/14/1995SE |
| K951491 | Dale Tracheostomy Tube Holder with Trach Mask Attachment TabsCBH · Traditional | Dale Medical Products, Inc. | 04/24/1995SE |
| K950930 | Trache-TiteCBH · Traditional | The Varner Group, Inc. | 03/22/1995SE |
| K950318 | Flex BlueCBH · Traditional | King Systems Corp. | 02/13/1995SE |
| K942395 | Endotracheal Tube HolderCBH · Traditional | S.T.I. Medical Products Corp. | 06/30/1994SE |
| K934288 | Holde.T. Endotracheal Tube Stabilization BarCBH · Traditional | Neo-Tech, Inc. | 06/09/1994SE |
| K942016 | Trach Tie, Ventilator Tubing HolderCBH · Traditional | Garrett Medical Products | 05/24/1994SE |
| K941384 | TrakeezCBH · Traditional | Ergomed, Inc. | 04/19/1994SE |
More from Ergomed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K902062 | Peep ValveBYE · Traditional | 09/04/1990SE |
| K900783 | Mdi AdaptorCAF · Traditional | 07/18/1990SE |
| K900470 | In-The NebulizerCAF · Traditional | 05/18/1990SE |
| K895589 | Manual ResuscitatorBTM · Traditional | 03/30/1990SE |
| K896136 | Infant C.P.A.P. MonitorCAP · Traditional | 01/09/1990SE |
| K895747 | Ventilarm II Portable Airway Pressure MonitorCAP · Traditional | 10/27/1989SE |
| K895231 | Catalog No. 1755 1S0-NEB, a Filtered NebulizerCAF · Traditional | 10/27/1989SE |
| K890035 | Bacteria FilterCAH · Traditional | 05/05/1989SE |
| K870895 | No. 1552, Valved Venti-CompCBP · Traditional | 05/04/1987SE |
| K871157 | C.P.A.P. Nasal CannulaBZD · Traditional | 04/21/1987SE |
Questions and answers
When was Endotracheal Tube Holder cleared by the FDA?
Endotracheal Tube Holder (K802601) received a 510(k) decision of Substantially Equivalent on December 18, 1980, 58 days after the submission was received.
What is the product code of K802601?
The FDA product code is CBH – Device, Fixation, Tracheal Tube, a Class I (low risk) device regulated under 21 CFR 868.5770.