FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEAD HOLDING DEVICE/SLEEP APNEA
K Number: K884493
·
Decision Jan 12, 1989
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
9
Applicant Total
4
Review Days
78
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HEAD HOLDING DEVICE/SLEEP APNEA
- K Number
- K884493
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1920
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- X-Ray Systems
- Date Received
- October 26, 1988
- Decision Date
- January 12, 1989
- Product Code
- IWY
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IWY | Holder, Head, Radiographic | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IWY), ordered by most recent decision date.
ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM
FDA 510(k)
FDA Class 1
·Radiology
MTD HEDREST
FDA 510(k)
FDA Class 1
·Radiology
DUOCEPH
FDA 510(k)
FDA Class 1
·Radiology
KELLER CEPHALOMETRIC DEVICE
FDA 510(k)
FDA Class 1
·Radiology
HEAD-SPINE STABILIZER HSS-1
FDA 510(k)
FDA Class 1
·Radiology
PORTA-STAT
FDA 510(k)
FDA Class 1
·Radiology