FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DELUXE WALL-MOUNTED CEPHALOMETER
K Number: K834559
·
Decision Feb 21, 1984
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
9
Applicant Total
2
Review Days
55
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Basic Information
- Device Name
- DELUXE WALL-MOUNTED CEPHALOMETER
- K Number
- K834559
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1920
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Knochen Dental Laboratory
- Date Received
- December 28, 1983
- Decision Date
- February 21, 1984
- 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 |
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Other Clearances by Knochen Dental Laboratory
| K Number | Device Name | ||
|---|---|---|---|
| K834606 | X-RAY COLLIMATOR X-CJD | Feb 21, 1984 | Substantially Equivalent |