FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLOOR MOUNTED X-RAY TUBESTAND
K Number: K843335
·
Decision Nov 27, 1984
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
39
Applicant Total
14
Review Days
92
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Basic Information
- Device Name
- FLOOR MOUNTED X-RAY TUBESTAND
- K Number
- K843335
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1770
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Medicor USA , Ltd.
- Date Received
- August 27, 1984
- Decision Date
- November 27, 1984
- Product Code
- IYB
- 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 |
|---|---|---|---|
| IYB | Tube Mount, X-Ray, Diagnostic | FDA class 1 | Radiology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K851358 | MODEL BION 2/TYPE 90 ROOM IONIZER | Jul 1, 1985 | Substantially Equivalent |
| K851094 | MODEL BION 1/TYPE 1084T CAR IONIZER | Jun 19, 1985 | Substantially Equivalent |
| K840227 | UROLIX-3 UROLOGICAL TABLE | Mar 23, 1984 | Substantially Equivalent |
| K840225 | C-ARM CEILING CRANE FT-2 | Mar 22, 1984 | Substantially Equivalent |
| K840226 | MOTOR TILTED EXAM. TABLE UV-56 | Mar 16, 1984 | Substantially Equivalent |
| K823695 | CPM METABOLIC MONITOR | Jan 14, 1983 | Substantially Equivalent |