FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARMBOARD
K Number: K833559
·
Decision Jan 3, 1984
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
5
Review Days
90
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Basic Information
- Device Name
- ARMBOARD
- K Number
- K833559
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Mtd, Inc.
- Date Received
- October 5, 1983
- Decision Date
- January 3, 1984
- Product Code
- KPR
- 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | FDA class 2 | Radiology |
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Other Clearances by Mtd, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K063439 | MEDICAL IMAGE MANAGEMENT DEVICES FOR VISION TOOLS | Jan 22, 2007 | Substantially Equivalent |
| K791374 | THE MTD VARA SET CASETTE HOLDER | Sep 7, 1979 | Substantially Equivalent |
| K772321 | ARTHROSTRESS | Jan 3, 1978 | Substantially Equivalent |
| K771659 | PATIENT RESTRAINT SYSTEM | Sep 30, 1977 | Substantially Equivalent |