FDA 510(k)
FDA class 1
Substantially Equivalent
🇯🇵 Japan
BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C
K Number: K895034
·
Decision Nov 15, 1989
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
20
Applicant Total
1
Review Days
99
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Basic Information
- Device Name
- BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C
- K Number
- K895034
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1880
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Yamato Medical Corp.
- Date Received
- August 8, 1989
- Decision Date
- November 15, 1989
- Product Code
- IXY
- 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 |
|---|---|---|---|
| IXY | Holder, Radiographic Cassette, Wall-Mounted | FDA class 1 | Radiology |
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