FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.)
K Number: K901956
·
Decision Jul 2, 1990
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
54
Applicant Total
16
Review Days
62
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Basic Information
- Device Name
- DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.)
- K Number
- K901956
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2010
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Eigen
- Date Received
- May 1, 1990
- Decision Date
- July 2, 1990
- Product Code
- LMB
- 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 |
|---|---|---|---|
| LMB | Device, Digital Image Storage, Radiological | FDA class 1 | Radiology |
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| K903821 | PSC-1 W/OTHER NUMERICAL | Nov 7, 1990 | Substantially Equivalent |