FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MOUNT TUBE RADIOGRAPHIC
K Number: K853682
·
Decision Sep 19, 1985
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
39
Applicant Total
4
Review Days
15
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Basic Information
- Device Name
- MOUNT TUBE RADIOGRAPHIC
- K Number
- K853682
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1770
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- X-Ray Systems
- Date Received
- September 4, 1985
- Decision Date
- September 19, 1985
- 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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