FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UROMAT 2000
K Number: K903395
·
Decision Aug 30, 1990
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
76
Applicant Total
8
Review Days
34
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Basic Information
- Device Name
- UROMAT 2000
- K Number
- K903395
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1980
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Pausch Corp.
- Date Received
- July 27, 1990
- Decision Date
- August 30, 1990
- Product Code
- IXR
- 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 |
|---|---|---|---|
| IXR | Table, Radiographic, Tilting | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IXR), ordered by most recent decision date.
VISION R/F TILTING TABLE
FDA 510(k)
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·Radiology
LEGACY/LEGACY-D TABLE
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CAP-35B III/CINE 275
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PHILIPS EASY DIAGNOST
FDA 510(k)
FDA Class 2
·Radiology
ELECTROPHYSIOLOGY TILT TABLE MODEL #9660
FDA 510(k)
FDA Class 2
·Radiology
FLUOROVIEW SERIES FLUOROSCOPIC TABLES
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Pausch Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K973864 | COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO | Jun 17, 1998 | Substantially Equivalent |
| K973834 | CS2000 & CS2000 TOMO | Apr 30, 1998 | Substantially Equivalent |
| K870856 | COSMOS | Mar 30, 1987 | Substantially Equivalent |
| K790742 | KS-78 VERTICAL WALL CASSETTE HOLDER | Apr 26, 1979 | Substantially Equivalent |
| K790740 | BS 66, UNIVERSAL BUCKY STAND | Apr 26, 1979 | Substantially Equivalent |
| K790741 | COMPACT SYSTEM | Apr 26, 1979 | Substantially Equivalent |
| K790743 | COORDINATUS, HORIZONTAL RADIOGRAPHOC | Apr 23, 1979 | Substantially Equivalent |