FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EP 3000
K Number: K924879
·
Decision Jan 4, 1993
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
299
Applicant Total
8
Review Days
98
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Basic Information
- Device Name
- EP 3000
- K Number
- K924879
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oec-Diasonics, Inc.
- Date Received
- September 28, 1992
- Decision Date
- January 4, 1993
- Product Code
- JAA
- 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 |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | FDA class 2 | Radiology |
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Other Clearances by Oec-Diasonics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K926056 | 9600 FLUOROSCOPIC IMAGING SYSTEM | Jan 21, 1993 | Substantially Equivalent |
| K914446 | UROVIEW 2000, MODIFICATION | Jan 10, 1992 | Substantially Equivalent |
| K896583 | F.A.S.T. TABLE | Mar 1, 1990 | Substantially Equivalent |
| K893475 | UROVIEW II | Aug 10, 1989 | Substantially Equivalent |
| K872022 | UROVIEW | Jul 16, 1987 | Substantially Equivalent |
| K864837 | MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM | Jan 30, 1987 | Substantially Equivalent |
| K843972 | ANGIOPLUS-S | Jan 3, 1985 | Substantially Equivalent |