FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACCULUPE
K Number: K955184
·
Decision Jan 24, 1996
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
54
Applicant Total
2
Review Days
72
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Basic Information
- Device Name
- ACCULUPE
- K Number
- K955184
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2010
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- E For M Imaging Systems Div., Marquette Electronic
- Date Received
- November 13, 1995
- Decision Date
- January 24, 1996
- 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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Other Clearances by E For M Imaging Systems Div., Marquette Electronic
| K Number | Device Name | ||
|---|---|---|---|
| K974504 | EPS | Feb 27, 1998 | Substantially Equivalent |