Cervical Collars & Head Halters
FDA 510(k) K850465 · Abco Dealers, Inc.
510(k) numberK850465
Submission
- Device name
- Cervical Collars & Head Halters
- Applicant
- Abco Dealers, Inc.
Milwaukee, WI, US - Received
- January 28, 1985
- Decision date
- April 25, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IQK – Orthosis, Cervical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3490
- Specialty
- Physical Medicine
Other 510(k)s with product code IQK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K930730 | Dormie Neck Support SystemIQK · Traditional | The Western Diagnostics Co. | 07/22/1993SE |
| K926291 | Schul-Tec ImmobilizerIQK · Traditional | Medical Emergency Support Equipment | 03/30/1993SE |
| K896042 | Medical Disposable BeddingIQK · Traditional | Keystone Veterinary Supplies, Inc. | 01/10/1990SE |
| K895477 | Nova PillowIQK · Traditional | Nova Health Systems, Inc. | 01/10/1990SE |
| K882264 | Battle Creek PillowIQK · Traditional | Battle Creek Equipment Co. | 08/09/1988SE |
| K832990 | Stifnick Immobilizing CollarIQK · Traditional | Laerdal California, Inc. | 11/07/1983SE |
| K832001 | Head-ImmobilizerIQK · Traditional | Int'L Safety Corp. | 07/12/1983SE |
| K831582 | Vari-Support Neck Posture PillowIQK · Traditional | Body Therapeutics, Inc. | 06/15/1983SE |
| K830351 | Disposable Extrication CollarIQK · Traditional | Deip Enterprises, Inc. | 03/09/1983SE |
| K830350 | Cervical PillowIQK · Traditional | Deip Enterprises, Inc. | 03/09/1983SE |
More from Deip Enterprises, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K905025 | Digital Thermometer KitsFLL · Traditional | 02/07/1991SE |
| K882304 | Digital Thermometer Sheaths (Oral and Rectal)FLL · Traditional | 07/12/1988SE |
| K880892 | Blood Collecting Needle and HoldersFMI · Traditional | 04/21/1988SE |
| K880894 | Allergist SyringesFMF · Traditional | 03/31/1988SE |
| K872875 | Stretch Gauze BandagesNAD · Traditional | 09/04/1987SE |
| K872874 | Microscope Cover GlassesKES · Traditional | 08/10/1987SE |
| K872797 | Non-Skid Shoe CoversFXP · Traditional | 08/04/1987SE |
| K871465 | Thermometer SheathsFLL · Traditional | 05/11/1987SE |
| K862726 | Disposable Shoe Covers and Nurses CapsFXP · Traditional | 08/01/1986SE |
| K862111 | Armboards, Reusable and Disposable · Traditional | 07/08/1986SE |
Questions and answers
When was Cervical Collars & Head Halters cleared by the FDA?
Cervical Collars & Head Halters (K850465) received a 510(k) decision of Substantially Equivalent on April 25, 1985, 87 days after the submission was received.
What is the product code of K850465?
The FDA product code is IQK – Orthosis, Cervical, a Class I (low risk) device regulated under 21 CFR 890.3490.