FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPECBOARD
K Number: K891090
·
Decision Apr 7, 1989
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
175
Applicant Total
4
Review Days
32
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Basic Information
- Device Name
- SPECBOARD
- K Number
- K891090
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1710
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Macbrud Corp. Medical Div.
- Date Received
- March 6, 1989
- Decision Date
- April 7, 1989
- Product Code
- IZH
- 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 |
|---|---|---|---|
| IZH | System, X-Ray, Mammographic | FDA class 2 | Radiology |
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