Dale Endotracheal Tube Holder 270/280
FDA 510(k) K964399 · Dale Medical Products, Inc.
510(k) numberK964399
Submission
- Device name
- Dale Endotracheal Tube Holder 270/280
- Applicant
- Dale Medical Products, Inc.
Plainville, MA, US - Received
- November 4, 1996
- Decision date
- January 28, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K940448 | Netoh Endotracheal Tube HolderCBH · Traditional | Medical Accessory Services, Inc. | 02/22/1994SE |
More from Medical Accessory Services, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K082241 | The Dale Ace Connector (Access Controller for Enteral), Model H84104751KNT · Traditional | 10/30/2008SE |
| K994300 | Nasogastric Tube Holder, Model 160KNT · Traditional | 02/10/2000SE |
| K961693 | Dale Gastrostomy Tube HolderPLI · Traditional | 07/30/1996SE |
| K951491 | Dale Tracheostomy Tube Holder with Trach Mask Attachment TabsCBH · Traditional | 04/24/1995SE |
| K914245 | Dale(R) Nasal Dressing Holder (Product No. 600)KGX · Traditional | 12/09/1991SE |
| K905231 | Dale Ventilator Tubing Support for Trach. Vent.CBH · Traditional | 01/14/1991SE |
| K894586 | Dale I.V. Identifier; Product #1125KMK · Traditional | 08/15/1989SE |
| K873311 | Dale I.V. Connect. Lock & Stabilizer (STABILOK)220KMK · Traditional | 11/05/1987SE |
| K864897 | Dale Venipuncture Tourniquet, Product No. 1335GAX · Traditional | 01/12/1987SE |
| K860583 | Dale Head Band Anesthesia Circuit Tube Holder 1315JAY · Traditional | 02/21/1986SE |
Questions and answers
When was Dale Endotracheal Tube Holder 270/280 cleared by the FDA?
Dale Endotracheal Tube Holder 270/280 (K964399) received a 510(k) decision of Substantially Equivalent on January 28, 1997, 85 days after the submission was received.
What is the product code of K964399?
The FDA product code is CBH – Device, Fixation, Tracheal Tube, a Class I (low risk) device regulated under 21 CFR 868.5770.