Dale Combo Tracheostomy Tube Holder
FDA 510(k) K812429 · Dale Medical Products, Inc.
510(k) numberK812429
Submission
- Device name
- Dale Combo Tracheostomy Tube Holder
- Applicant
- Dale Medical Products, Inc.
Mchenry, IL, US - Received
- August 25, 1981
- Decision date
- September 23, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EQH – Source, Carrier, Fiberoptic Light
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4350
- Specialty
- Ear, Nose, Throat
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More from Electro Fiberoptics Corp.
| 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 |
| K964399 | Dale Endotracheal Tube Holder 270/280CBH · Traditional | 01/28/1997SE |
| 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 |
Questions and answers
When was Dale Combo Tracheostomy Tube Holder cleared by the FDA?
Dale Combo Tracheostomy Tube Holder (K812429) received a 510(k) decision of Substantially Equivalent on September 23, 1981, 29 days after the submission was received.
What is the product code of K812429?
The FDA product code is EQH – Source, Carrier, Fiberoptic Light, a Class I (low risk) device regulated under 21 CFR 874.4350.