HEAD-IMMOBILIZER
FDA 510(k) clearance K832001 · decided 1983-07-12
Clearance details
- K-number
- K832001
- Device name
- HEAD-IMMOBILIZER
- Applicant
- Int'L Safety Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-06-22
- Decision date
- 1983-07-12
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- IQK
- Device class
- 1
- Regulation number
- 890.3490
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DORMIE NECK SUPPORT SYSTEM (K930730) | The Western Diagnostics Co. | 1993-07-22 |
| SCHUL-TEC IMMOBILIZER (K926291) | Medical Emergency Support Equipment | 1993-03-30 |
| NOVA PILLOW (K895477) | Nova Health Systems, Inc. | 1990-01-10 |
| MEDICAL DISPOSABLE BEDDING (K896042) | Keystone Veterinary Supplies, Inc. | 1990-01-10 |
| BATTLE CREEK PILLOW (K882264) | Battle Creek Equipment Co. | 1988-08-09 |
| CERVICAL COLLARS & HEAD HALTERS (K850465) | Abco Dealers, Inc. | 1985-04-25 |
| STIFNICK IMMOBILIZING COLLAR (K832990) | Laerdal California, Inc. | 1983-11-07 |
| VARI-SUPPORT NECK POSTURE PILLOW (K831582) | Body Therapeutics, Inc. | 1983-06-15 |
| CERVICAL PILLOW (K830350) | Deip Enterprises, Inc. | 1983-03-09 |
| VINYL EXTRICATION COLLAR (K830348) | Deip Enterprises, Inc. | 1983-03-09 |
| DISPOSABLE EXTRICATION COLLAR (K830351) | Deip Enterprises, Inc. | 1983-03-09 |
| CERVICAL COLLAR (K823667) | Warm & Form, Orthopedic Materials | 1982-12-30 |
Recalls involving this device
No recalls on record reference this clearance.